Sjs Executives Llc Jobs in Usa

What Makes a Honda, is Who makes a Honda
Honda has a clear vision for the future, and it’s a joyful one.  We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record success.  We strive to be a company that serves as a source of “power” that supports people around the world who are trying to do things based on their own initiative and that helps people expand their own potential. To this end, Honda strives to realize “the joy and freedom of mobility” by developing new technologies and an innovative approach to achieve a “zero environmental footprint.”

We are looking for qualified individuals with diverse backgrounds, experiences, continuous improvement values, and a strong work ethic to join our team.

If your goals and values align with Honda’s, we want you to join our team to Bring the Future!

Applies broad theoretical knowledge in Regional Spec Control Operations. Manage and administer NA Regional and Global engineering drawings and manufacturing design revision issuance to all North American and Global plants as needed. Development, configuration, management, and verification of the technical data in the Manufacturing Bill of Material thru execution of Engineering Design Changes and revisions from NA manufacturing plants from Manufacturing Instructions. Contribute to the stable production start of New Models and products in mass production by focusing on quality & efficiency in execution of the engineering change management process.

• Design Change Delivery - BEAM Bill of Material System Setting: handling engineering technical records and project information for individual design changes or full BOM design changes - Design drawing review, part hierarchy/ structure change point confirmation, understand Inter / Intra company part supply relationships. Interpret regional and global parts supply/install agreements to ensure data is sent to correct plants. Understand each models feature and application list change points. Understanding and configuration of Frame/Engine/Transmission /Differential combination set up and combination changepoint reconversions, apply reason codes by change point to support supplier/factory instruction sheet issuance.

• Manufacturing Instruction Delivery - BEAM Bill of Material setting: handling engineering technical data by configuration of Part Drawing Manufacturing Change Points, confirmation of part hierarchy, quantity, application accuracy, understand Inter / Intra company part supply relationships, understanding of in-house delivery set up, interpret regional and global parts supply / install agreements to ensure data is sent to correct plants, understanding of feature and application list change points, understanding and configuration of Frame / Engine / Transmission / Differential combination set up and combination changepoint reconversions, apply reason codes by change point to support instruction sheet issuance and VIN capture, determine need to request supplier or plant supply setting, quantities confirmation and splitting, confirmation of application at multiple plants, verification of originating department content / objective.

• Export Bill of Material – Mgmt. of parts supplied from North America to the world.. Communication with multiple regions for application timing, part color setting, model build process kick-off & execution. Address customer inquiries / concerns promptly and professionally to ensure customer satisfaction. Build customer relationships and teamwork. Attend and support BOM and New Model meetings with North America International Operations Office (NAIOO) as needed.

• Communication & Coordination –Facilitate or support all North America plants / departments with design and engineering Bill of Material clarification & configuration information per Operational Rules and support New Model meetings as needed.

• Business Plan Themes – Leading or participating in a team that will execute strategic business initiatives. Theme work may include: process maps, calculations of benefits/ efficiency, time studies, or multi department collaboration. Teams report status monthly/quarterly to management to communicate/share progress on theme.

▪ BAS Degree, or equivalent relevant experience Minimum Experience
▪ 0–4 years of experience with Part Drawing Control or Engineering Change Mgmt., Supplement Experience in Supply Chain, Production Control or Manufacturing Engineering is a plus. Other Job-Specific Skills
▪ Recognize and demonstrate knowledge of BOM/Parts List Check procedure.
▪ Recognize and demonstrate knowledge of Specification Notice Procedures issuance/ management. (D/C and MI)
▪ Recognize & demonstrate Honda Engineering Standards Knowledge
▪ Recognize & demonstrate CATIA Knowledge
▪ Recognize & demonstrate new model development flow knowledge
▪ Recognize & demonstrate data modelling knowledge
▪ Recognize & demonstrate product maker layout flow knowledge
▪ Understand importance of technical data quality accuracy and integration
▪ Excel (macro knowledge a +), PowerPoint

What differentiates Honda and make us an employer of choice?

Total Rewards:

• Competitive Base Wages (pay will be based on several variables that include, but not limited to geographic location, work experience, etc.)
• Paid Overtime
• Regional Bonus (when applicable)
• Industry-leading Benefit Plans (Medical, Dental, Vision, Rx) 
• Paid time off, including vacation, holidays, shutdown
• Company Paid Short-Term and Long-Term Disability 
• 401K Plan with company match + additional contribution

Career Growth:

• Advancement Opportunities
• Career Mobility
• Education Reimbursement for Continued Learning
• Training and Development Programs 

Additional Offerings:

• Lifestyle Account
• Childcare Reimbursement Account
• Tuition Assistance & Student Loan Repayment
• Elder Care Support
• Wellbeing Program
• Community Service and Engagement Programs
• Product Programs

Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.

Associate Project Leader

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower-level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Associate Project Leader:

-Bachelor's degree, preferably in a scientific discipline, with at least 6 years of experience within pharma and/or CRO;

-Master's degree with at least 4 years of experience within pharma and/or CRO;

-PhD with at least 1 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles appropriate to the position with a typical tenure of at least 1 year management experience in a research environment.

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  Highly motivated with ability to work independently and as part of a multi-disciplinary team
  Strong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Job Title: Project Delivery Manager (Ophthalmology) - OptymEdge

Location: Remote in US, Canada & UK

OptymEdge, (part of the Emmes Group), develops proven solutions for training and certification of Visual Function Examiners and Visual Acuity Rooms. OptymEdge partners with study teams to provide visual function certification that ensures a high level of quality and consistency for ophthalmic clinical trial data.

OptymEdge is the largest and longest-standing certification organization in the industry. We pioneered visual acuity certification from conception. Our services have grown to be synonymous with providing the highest level of quality and standardization of clinical trial data.

• Over 2,500 sites certified worldwide, since 1995

• Phase I through post-marketing experience across anterior segment and retina trials

• Clinical Ophthalmology, Optometry, and clinical trial expertise

Primary Purpose

The Project Delivery Manager (PDM) is critical to the successful conduct of ophthalmic certifications in Biopharmaceutical-sponsored clinical trials, as a matrix leader of a vendor project team. The OCPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The PDM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through strong relationship management.

* Serves as the primary point of contact for biopharma clients and demonstrates proficiency in knowledge and understanding of client needs.
* Ensures that deliverables for the assigned projects are completed according to the contract budget, schedule, and quality standards. Projects will be effectively managed in all areas of performance.
* Develops successful working relationships with clients, executive management, and project staff and collaborates to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
* Tracks project deliverables against contract. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and agrees to mitigation plans with the project team to be presented to the client.
* Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
* Identifies and manages changes to scope and requests for out-of-scope activities. Collaborates with Business Development, Contracts Department, and executive management to ensure timel y execution of contract amendments/change orders. Prospectively manages client expectations.
* Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
* Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
* Performs other duties as assigned.

* Bachelor's degree or equivalent experience.

* Experienced in developing and maintaining customer relationships.
* Minimum 2 years demonstrating related experience.

* Experience with MS Office Suite.
* Time management and decision-making skills.
* Attention to detail and the ability to address several assignments simultaneously.
* Excellent oral and written communication skills.
* Some knowledge of clinical trials in ophthalmology preferred.

* Occasional travel may be required on an ad hoc basis

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

Accountable for successful delivery of clients' statement of work within budget on clinical research projects, maintains a positive relationship with clients, supervises project leaders, mentors staff, and works collaboratively with Business Development to help generate new business.

• Accountable for technical, scientific, fiscal, and overseeing of research projects working with staff from other verticals at Emmes responsible for research support activities, including but not limited to Clinical Operations, Statistical and Scientific Innovation, Regulatory Affairs, and Pharmacovigilance.
• Proactively assesses client expectations and addresses client's needs for ongoing studies/support and engages with clients for new opportunities in support of future studies.
• Reviews, provides input on, and approves project and study documents and processes, as needed.
• Represents the project or company at client meetings and scientific conferences.
• Utilizes broad understanding of therapeutic, clinical trial design, and/or process expertise to influence and executes project decisions considering client needs, budget considerations and the current state of the research field.
• Defines solutions with input from team members that will be implemented to meet client's needs that address contractual aspects of projects (e.g., project contracts, scope of work, budgets, subcontracts, vendor agreements) to ensure delivery of high-quality contract deliverables.
• Defines solutions with input from team members that will be implemented to mitigate risk and communicate risks and contingencies with clients.
• Approves initial budgets and statement of work documents and subsequent modifications before distribution to clients.
• Liaises with corporate services and leaders from other Emmes verticals and departments to ensure staff resources are adequate within the project team to successfully meet the client's requirements.
• Participates in project review meetings with TRU Directors and/or TRU Oversight, and Commercial and Service Project Oversight, if applicable.
• Uses established key performance metrics to assure successful delivery of the project that meet client requirements.
• Supervises, mentors, and supports lower level project leaders (if applicable) to ensure they are properly trained for their current positions and have growth and development opportunities.
• Mentors project staff from other verticals pursuing a Project Leader role within the Therapeutic and Research Units.
• Participates in relevant corporate meetings and provides information learned and best practices to project team as applicable. Implements relevant corporate initiatives directed towards Project Leaders and therapeutic research areas, taking into account project budget considerations.
• Provides support to the Chief Business Officer as a subject matter expert in a therapeutic or research area and discusses business opportunities with clients and study collaborators, as appropriate.
• Contributes to the development of operational strategy, budget, and proposal content for new business opportunities.

Education/Requirements

Project Leader: Bachelor's degree, preferably in a scientific discipline, with at least 8 years of experience within pharma and/or CRO; Master's degree with at least 6 years of experience within pharma and/or CRO; PhD with at least 3 years of experience within pharma and/or CRO

• Demonstrated working knowledge of the principles of clinical trial management and operations with at least 3 years of management experience in a research environment

• Prior CRO/clinical trial management of late-stage clinical trials preferred

• Demonstrable track record of success delivering complex/high-priority clinical trials within the agreed time, quality, and cost

• Demonstrated strong problem solving and analytical skills, combined with sound business judgment

• Ability to work proactively and effectively, with creative problem-solving and collaboration skills
  Highly motivated with ability to work independently and as part of a multi-disciplinary team
  Strong cross-functional project management and time management skills

• Excellent verbal and written communication skills

• Experience in therapeutic research areas that will align with Emmes' expertise, including substance use and mental health is strongly preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Safety Monitor II

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Safety Monitor II will implement Pharmacovigilance activities in collaboration with other members of the Pharmacovigilance and Medical Monitoring (PMM) department, under general supervision. The Safety Monitor II will assist senior level Safety Monitors with interventional and non-interventional clinical projects in conjunction with the assigned Medical Monitor/Medical Officer and the project team and may be assigned as the Primary Safety Monitor for small projects. In addition, the Safety Monitor II will assist with the designing and execution of the assigned Pharmacovigilance (PV) related projects (e.g., management of local or international PV systems for contracted Clients; PV supervision of RWE (Real World Evidence projects); etc.) in close cooperation with other Emmes roles, especially with Medical Officers/Medical Monitors (or other similar medical expert roles), Regulatory roles, etc. The Safety Monitor II will support the adherence to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and other relevant Pharmacovigilance requirements.

• Assists in performing safety monitoring activities in cooperation with project Medical Monitor/Medical Officer and other relevant project team members.
• Reviews safety events.
• Assists in the collection, assessment, monitoring, review and reporting of adverse drug reaction cases from all sources clinical (both interventional and non interventional), data sets analyzed in association with RWE projects, spontaneous reports, literature, etc.
• Provides first line evaluation of serious adverse events (SAEs).
• Communicates with site staff regarding reported AEs or SAEs to gather additional information.
• Prepares a summary narrative for each reported SAE suitable for Medical Monitor/Officer review, and inclusion in Data Safety Monitoring Board (DSMB) reports, regulatory submissions, and final study reports.
• Coordinates the timely completion and submission of required reports to health authorities and business partners.
• Maintains ongoing database of SAEs and reconciles SAEs in the database as needed.
• Reviews adverse events and/or other safety related data such as toxicities, concomitant medications and medical history, etc. for the study on a regular basis.
• Establishes direct communication with Client, investigator site staff, national and regional regulatory authorities, health professionals, pharmaceutical and other study partners, as necessary.
• Responds to site, Client, DSMB, or Medical Monitor/Officer requests for information regarding safety in clinical trials (both interventional and non interventional).
• Participates in DSMB or other safety review committee (SRC) meetings, including Protocol Safety Review Team (PSRT) meetings, as necessary.
• Reviews and contributes to DSMB/SRC reports regarding safety; reviews and contributes to safety sections of annual as well as periodic safety reports.
• Coordinates with project staff.
• Participates in project team meetings for the planning, preparation, and development of all safety related sections of protocols, study specific safety documents such as Safety Management Plan (SaMP), Manual of Operations (MOP), project Standard Operating Procedures (SOPs), and ancillary documents to ensure project compliance with corporate SOPs.
• Contributes to the development and implementation of safety related Case Report Forms (CRF) and SaMP.
• Ensures maintenance of documentation required by both corporate and project SOPs.
• Participates in project process improvement and corporate quality assurance activities through Internal Quality Audit Team (IQAT) processes, project SOP and Compliance/Variance table development, participation in both internal and external audits, as well as professional development activities.
• Performs Medical Dictionary for Regulatory Activities (MedDRA) and World Health Organization (WHO) Drug coding, as applicable.
• Guarantees compliance and adherence to the quality standards.
• Contributes to the development and maintenance of departmental quality documents (e.g., SOPs) and other work practices as assigned.
• Maintains accurate reporting to relevant authorities, such as Food and Drug Administration (FDA), European Medicines Agency (EMA) etc. when applicable per client contract.
• Contributes to the verification that Quality Control processes are conducted in accordance with applicable written procedures.
• Completes all relevant professional training in the given scope and time frame.
• Participates in corporate activities such as corporate safety meetings/activities; annual SOP reviews; cross department working groups dedicated to improvement of the work processes and development of innovative solutions and other relevant corporate initiatives.

• Bachelor's Degree in Pharmacology, nursing or other scientific discipline is required with relevant experience in clinical practice, example pharmacy, inpatient or outpatient healthcare facility, or clinical research center.
• 1-3 years in research or with a pharmaceutical company (CRO, SMO, pharma company, etc.) required
• Experience in safety monitoring/pharmacovigilance preferred

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Global Project Manager - Ophthalmology

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

The Global Project Manager (GPM) is critical to the successful conduct of Biopharmaceutical -sponsored clinical trials as a matrix leader of the core project team. The GPM is responsible for the successful delivery of a Biopharmaceutical project(s). The GPM will be client-facing and serve as the internal lead of the project through the life cycle of the study, ensuring effective project delivery in agreement with contracted project timeline and budget. The GPM directs project delivery by driving team and financial efficiency, work product quality, and is responsible for client satisfaction through relationship management.

• May serve as a primary lead for project bids and multi trial initiatives.
• Ensures that deliverables for assigned project(s) are completed according to the contract budget, schedule, and quality standards. Effectively manages projects in all areas of performance.
• Develops effective working relationships with clients, executive management, and project staff. Collaborates with stakeholders to manage project issues, proactively identify and mitigate risks and drive milestone achievement.
• Serves as the primary point of contact for biopharma clients. Demonstrates proficiency in knowledge and understanding of client needs.
• Tracks project deliverables against contract using Emmes' tools. Proactively prepares/presents study metrics to maintain transparency for internal/external stakeholders. Monitors trends and drives changes to the plan as needed; identifies risks to delivery and collaborates with the project team to develop mitigation plans to be presented to the client.
• Ensures adherence to quality control expectations and milestone timelines for delivery of contractually required reports and deliverables.
• Manages project resources (i.e., budget, personnel, and subcontracts).
• Identifies and manages change to scope and requests for out-of-scope activities. Collaborates with Business Development, the Contracts Team, and executive management to ensure timely execution of contract amendments/change orders. Prospectively manages client expectations.
• May present in bid defense meetings in collaboration with Business Development.
• Develops study management plans in collaboration with core project team members.
• Identifies and documents lessons learned from study successes and challenges to promote development of best practices.
• Models and propagates Emmes' commitment to a culture of quality in all aspects of our deliverables, utilizing a solution-based, science-driven, value-added approach in collaborating with clients.
• Performs other duties as assigned.

• Bachelor's degree in a scientific discipline.
• Minimum 8 years demonstrating scientific principles appropriate in managing a clinical research portfolio including multi-phase research experience in a broad range of indications and client types.
• At least 3 years working in a pharmaceutical and/or CRO setting, serving in a global Trial Team Lead or Global Project Management role or equivalent position.
• Minimum of 2 years of experience in Ophthalmology clinical trials, 5 years of experience preferred.
• Demonstrable track-record of success delivering complex/ high priority clinical trials within agreed time, quality and cost working across multiple therapeutic areas, phases 1-4, in a global capacity.
• Demonstrated experience in developing and fostering client and internal relationships.
• Thorough understanding of ICH GCP and applicable global regulatory regulations and
  guidelines.
• Skilled in MS Office Suite of products and working knowledge of Clinical Trial Management Systems, electronic Trial Master File, and electronic Data Capture systems and solutions.
• Successful record in managing diverse staff and leading strong teams.
• Strong verbal and written communication skills.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off

• Tuition Reimbursement

• 401k Retirement Plan

• Work From Home Anywhere in the US

• Maternal/Paternal Leave

• Casual Dress Code & Work Environment

CONNECT WITH US!

Follow us on Twitter - @EmmesCRO

Find us on LinkedIn - Emmes

The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.

#LI-Remote

Job Description

AES Restaurant Group is seeking a dedicated and experienced Area Supervisor (District Manager) to oversee operations across multiple locations within our organization. The ideal candidate will have a strong background in food service, particularly in a quick service environment. This role requires exceptional leadership skills, a passion for training and development, and the ability to manage shifts effectively while ensuring high standards of service and quality.

Duties

• Supervise daily operations across assigned locations, ensuring compliance with company policies and procedures.
• Train, mentor, and develop staff to enhance their skills and improve overall performance.
• Implement training programs that focus on service excellence, food safety, and operational efficiency.
• Approve restaurant schedules to ensure adequate staffing levels during peak hours.
• Oversee inventory management, including ordering supplies and minimizing waste.
• Collaborate with management to develop strategies for improving service quality and operational efficiency.
• Address customer inquiries and resolve any issues that arise during service promptly.
• Foster a positive work environment that encourages teamwork and professional growth.

Experience

• A minimum of two years’ experience in a supervisory role within the food service industry, preferably in quick service fast food restaurants.
• Excellent customer service skills with the ability to handle challenging situations effectively.
• Demonstrated ability in staffing, training and development, with a focus on operations execution of effective training programs.
• Excellent communication skills with the ability to lead diverse teams effectively.
• Experience in shift management is essential for maintaining operational flow during busy periods.
• Strong leadership skills with the ability to motivate and inspire team members.

Benefits:

• Medical, vision, dental insurance
• Employee discount
• Flexible schedule
• Paid time off
• Paid training
• Performance based bonuses
• Company Car
• Free Meals while working

Shift availability:

• Day Shift (Required)
• Some weekend work required
• 5.5 Days; 50 hours per week

Work Location:

• Traveling to various restaurant locations within designated area

AES Restaurant Group, LLC, and its affiliates, are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, creed, marital status, familial status, public assistance status, or any other characteristic protected by law.

General Summary

As the Director of Maintenance, you will be the on‑site authority guiding all maintenance and service operations to ensure aircraft are safe, airworthy, and ready for flight. You'll oversee maintenance activities in full alignment with FAA regulations, the Quality Control Manual (QCM), the Repair Station Manual (RSM), and all approved maintenance data. Your leadership ensures every aircraft is maintained and released to service in full compliance with 14 CFR Part 145.

In this pivotal role, you will provide the strategic direction, hands‑on leadership, and regulatory accountability that keeps our maintenance organization operating at peak performance. You'll lead and mentor maintenance teams, oversee maintenance planning, and drive the daily execution of service operations at your assigned location-all while fostering a culture of safety, quality, and operational excellence.

Primary Responsbilities

Regulatory & Airworthiness Oversight

• Ensure compliance with 14 CFR Part 145, Repair Station Manual, Quality Manual, and applicable FAA guidance.
• Ensure maintenance is performed using approved technical data and proper procedures.
• Ensure proper execution of return-to-service documentation.
• Support FAA, customer, and third-party audits and ensure corrective actions are implemented and sustained.
• Coordinate with Quality and Engineering on regulatory interpretation and compliance matters.

Maintenance & Service Execution

• Direct all maintenance, inspection, repair, and modification activities at the site.
• Ensure effective planning, sequencing, and control of maintenance work.
• Ensure personnel, tooling, facilities, and materials are adequate for assigned work.
• Conduct daily production oversight to ensure safe, compliant, and timely execution.

Safety Management

• Promote and enforce a safety-first culture in accordance with the company Safety Management System (SMS).
• Ensure hazards, incidents, and near misses are reported and addressed.
• Support investigations and corrective actions related to maintenance events or deviations.

Personnel & Training

• Ensure maintenance personnel are properly trained, qualified, and authorized to perform assigned tasks.
• Ensure compliance with training, certification, and recurrent qualification requirements.
• Provide leadership, direction, and accountability to maintenance supervisors and staff.

Operational Performance

• Monitor and manage performance related to schedule adherence, labor utilization, and rework.
• Identify and address operational constraints impacting compliance, safety, or delivery.
• Support coordination with Planning, Parts, Quality, and Customer Experience functions.

Top Candidates Will Possess

• Bachelor's degree in Aviation Management, Business or related field preferred
• Minimum 10 years aircraft maintenance experience
• Minimum 5 years in a maintenance leadership role within a Part 145 environment
• FAA Airframe & Powerplant (A&P) certificate required
• Deep understanding of business aviation airframes, powerplants, and diagnostics
• Strong working knowledge of FAA Part 145 (and Part 91/135 interfaces), safety management systems, and quality assurance principles
• Ability to troubleshoot complex maintenance issues and guide teams through efficient, compliant resolutions
• Proficient in planning, workflow optimization, scheduling, and resource allocation
• Strong communicator capable of translating technical issues into clear, customer‑friendly information
• Builds trust with aircraft owners, operators, and OEMs through transparency and exceptional service delivery
• Drives long‑range planning, departmental budgeting, capacity forecasting, and capability development
• Identifies new service opportunities, efficiencies, and technology integrations to keep the MRO competitive
• Inspires, coaches, and builds high‑performing maintenance teams
• Demonstrates calm, confident decision‑making in high‑pressure operational environments

About Us:

Trilliant Food & Nutrition is a leading, vertically integrated manufacturer of premium coffees and powdered beverages, proudly headquartered in Little Chute, Wisconsin. With a legacy rooted in quality, innovation, and service, Trilliant delivers branded and private label solutions across retail, foodservice, and e-commerce channels.

Horseshoe Beverage Company, based in Neenah, WI, is a leading ready-to-drink beverage manufacturer dedicated to delivering an exceptional beverage experience. By combining industry-leading talent, cutting-edge equipment, and a vertically integrated supply chain, we drive innovation and consistently deliver the highest quality products to our customers—first and fast.

Our brand portfolio includes Victor Allen’s®, Dutch Bros® beverages and Nurri™, our better-for-you protein beverage line. We are passionate about beverages – and about building a team that’s just as energized. We invite you to explore opportunities at Trilliant or Horseshoe, to see if your talents and career aspirations may fit with our openings.

Position Overview:

Driven by a relentless pursuit of operational excellence, the Maintenance Manager in the Trilliant Food & Nutrition family will lead all reliability and maintenance initiatives to unlock the full potential of plant performance. This role is pivotal in fostering cross-functional collaboration across operations, engineering, quality, and logistics; while championing a culture of safety, accountability, and continuous improvement.

The ideal candidate will bring deep technical expertise, strategic leadership, and a passion for developing high-performing teams. This position oversees all aspects of maintenance management, including asset reliability, budget control, CMMS utilization, and regulatory compliance.

Responsibilities:

Safety & Compliance Leadership

• Champion a safety-first culture across all maintenance operations
• Ensure strict adherence to safety protocols for employees and contractors
• Maintain compliance with USDA, FDA, OSHA, and EPA regulations

Cost Optimization & Asset Management

• Develop and manage the maintenance budget to optimize costs and reduce waste
• Implement cost-effective asset management strategies to extend equipment life
• Oversee maintenance inventory and vendor relationships to ensure parts availability and economic stockroom practices

Reliability & Maintenance Execution

• Maximize equipment uptime through predictive, preventative, and corrective maintenance programs
• Leverage CMMS data to plan and execute maintenance and project activities
• Coordinate major maintenance and capital projects with manufacturing and engineering teams

Data-Driven Decision Making

• Report and analyze weekly/monthly KPIs to drive proactive maintenance strategies
• Conduct reliability studies to identify CAPEX opportunities and operational improvements
• Lead root cause analysis (RCA) initiatives and share best practices across departments

Team Development & Leadership

• Mentor maintenance staff in technical skills, CMMS usage, and problem-solving methodologies
• Set and evaluate departmental goals in collaboration with plant leadership
• Manage performance, training, and development plans for all maintenance personnel

Continuous Improvement & Strategic Initiatives

• Partner with CI teams and operations leaders to implement Lean and Six Sigma improvements
• Lead change initiatives and facilitate improvement projects across the plant

Facility & Utility Oversight

• Ensure utilities (air, steam, water, nitrogen, glycol, etc.) and wastewater systems meet production demands
• Maintain facility and equipment per GMP standards to meet internal and external expectations
• Support capital planning through evaluation of facility, utility, and equipment reliability

Additional Responsibilities

• Execute duties assigned by the Director of Manufacturing to support factory operations

Qualifications:

• Bachelor’s degree in Mechanical Engineering, Industrial Maintenance, or related technical field preferred
• Minimum 7 years in operations, maintenance, or engineering; 10+ years in managerial leadership

• Strong expertise in packaging/mechanical systems, electrical, automation/PLC, and utility systems (boiler, glycol refrigeration, wastewater)

• Proven ability to lead, coach, and develop diverse teams

• Excellent analytical, organizational, and communication skills

• Strong CMMS experience; skilled in RCA, predictive maintenance, and continuous improvement

• Ability to manage a 24/7 continuous operation

Compensation: We offer a competitive salary that meets cost of living and a comprehensive benefits package for full-time employees.This position works at our Little Chute, WI manufacturing facility.

Physical and Mental Demands:

• While performing the duties of this job, the employee is frequently required to sit, hear, use hands to type data, use a personal computer and telephone. This employee may occasionally have to operate business machines and lift and/move up to 50 pounds.
• Specific vision abilities required in this job include close vision and the ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Mental demands include multi-tasking, decision making, problem solving, comparing, copying, computing, compiling, analyzing, coordinating, and synthesizing data.
• Potential for exposure to chemicals, heights, loud noises, mechanical equipment, wet environments, and other potential hazards exists.

Safety Statement:

At Trilliant and Horseshoe, safety is every employee’s first responsibility. We expect all employees to adhere to all safety practices, have the moral courage to stop other individuals from performing unsafe acts, and immediately report unsafe conditions.

Disclosures:

• The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
• Responsible for following food safety/regulatory policies and procedures, executing responsibilities as identified in standard operating procedures, and reporting food safety/regulatory concerns to the Production or Quality Manager.
• Trilliant Food & Nutrition and Horseshoe Beverage Company are Drug Free Workplaces. All applicants are subject to a drug screen and background check as a condition of employment.
• Trilliant Food and Nutrition and Horseshoe Beverage participate in the E-Verify process.
• EEO/AA including Vets and Disabled
• If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information.
• Trilliant Food and Nutrition and Horseshoe Beverage are Equal Opportunity Employers.
• The principles of the OECD and UN have been taken into consideration and used as guidance in our human rights practices and procedures.