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The company is a compelling, fast-growing, clinical-stage biopharmaceutical company focused on transforming metabolic disorders through innovative therapeutics.
With expanding clinical development efforts, we are seeking an experienced Associate Director of QMS and Vendor Management Quality to join the team and help ensure the highest standards of quality across our clinical programs, reporting to the Head of Clinical and non-CMC Quality.
This will be a hybrid position, with a minimum of two days per week in the office in San Francisco. This position may require domestic and international travel up to 25%.
Position Summary
The Associate Director of QMS and Vendor Management Quality, under the direction of the Head of Clinical and non-CMC Quality, will be responsible for effectively supporting GXP compliance; developing, implementing, and continuously improving our Quality Management System (QMS), overseeing the vendor management program, and GxP IT compliance.
This role ensures adherence to the global regulations across clinical, nonclinical, and CMC activities and oversees the company's QMS, vendor management, and GxP computerized systems. This will include, but not be limited to:
- Procedures development, review and approval
- Management and review of quality documentation, quality events/deviations and issue resolution, CAPAs and investigations
- Change control management
- Inspection readiness
- Audits and inspections
- Product complaints
- Conduct and oversee risk assessments
- Regulatory compliance, and effective quality oversight of internal functions and external vendors throughout the product lifecycle.
The ideal candidate brings a strong background in Quality within a small or start-up biotech environment and is comfortable operating in a dynamic, fast-paced and hands-on role. The ideal candidate has an energetic, engaging, and agile personality; we are looking for a quality-oriented, proactive achiever with high integrity.
Key Responsibilities:
Quality Systems Management:
- Lead development, implementation, maintenance, and continuous improvement of the QMS in alignment with FDA, ICH, EMA, and other applicable global regulations.
- Establish and maintain core quality systems, including Deviation, CAPA, and Investigation Management, Change Control, Risk Management, and Audit and Inspection Management systems.
- Ensure QMS scalability to support IND, Phase 1/3, and future commercialisation activities
- Design, implementation, administration, and continuous improvement of the Document Management System (DMS) and/or electronic Quality Management System (eQMS)
- Work closely with Clinical Operations, Clinical Development, Non-Clinical, IT, Regulatory Affairs, Pharmacovigilance, and Quality teams to identify, assess, and resolve quality issues.
- Collaborate cross-functionally to promote a culture of quality and compliance
- Author, review, and approve SOPs and quality documents in collaboration with functional stakeholders.
- Ensure inspection readiness and support regulatory inspections.
- Manage quality metrics and lead governance forums.
Vendor Management Program:
- Own the vendor qualification and oversight process.
- Manage Approved Vendor List, audit schedules, vendor files
- Schedule, lead/perform audits, performance reviews, and vendor lifecycle oversight, as needed.
- Ensure appropriate QA provisions in contracts and Quality Agreements, as needed.
QA Oversight of IT Compliance:
- Oversee validation and lifecycle management of GxP systems.
- Ensure compliance with 21 CFR Part 11, Annex 11, ALCOA+.
- Approve validation documentation (URS, IQ/OQ/PQ).
- Conduct IT vendor audits and system reviews.
Quality Oversight & Cross-Functional Support:
- Provide QA support across clinical, nonclinical, and CMC.
- Review applicable to functional operations deviations, CAPAs, investigations, and change controls.
- Support inspection readiness.
Qualifications Required:
Education and Experience Requirements
- Bachelor’s degree in Life Sciences required; advanced degree preferred.
- 8+ years of GxP QA experience.
- 3+ years of vendor management and audit experience.
- Experience with computerized systems validation.
- Knowledge of FDA, EMA, MHRA, TGA, ICH, and 21 CFR Part 11.
Core Competencies:
- Excellent oral and written communication, collaboration, and auditing skills are desired.
- High attention to detail, excellent organisational skills, and the ability to work on multiple projects with tight deadlines are desired.
- Experience communicating with both domestic and international collaborators with an awareness of cultural diversity.
- Ability to build scalable programs.
- Previous participation in regulatory agency inspections is preferred.
- Experience in small or start-up biotech environments is preferred.
If you are interested in having the opportunity to work with a passionate, innovative, and mission-driven team, and be emboldened to meaningfully impact this nimble, high-growth company, then this may be the opportunity for you!
Please note - the onsite requirement in San Francisco is non-negotiable, and we cannot support any costs for candidates wishing to relocate.
Role: Director of Quality Assurance- INSURANCE INDUSTRY
Location: Must be able to go onsite in Lake Mary, FL
Salary: $210k with 3% bonus
Company benefits include Health Care, Dental and Vision Care, 401K
MUST HAVE Successful history of driving modernization of testing frameworks and practices in Financial Services preferably across Personal and Commercial Lines Insurance
What you can expect as a Director of Quality Engineering:
• Serve as a trusted advisor to Business, Product, and Technology leaders, championing enterprise-wide Quality Engineering practices across core platforms, digital channels, and integrations.
• Define, own, and govern the enterprise Quality Engineering strategy, roadmap, operating model, and standards aligned to business transformation and technology modernization.
• Lead the shift from traditional testing to engineering-driven, automation-first, and risk-based quality practices to reduce manual testing effort and accelerate delivery.
• Embed quality as a shared accountability across Agile and Product teams through Shift Left, DevOps integration, and continuous quality practices.
• Influence enterprise technology strategy by advocating for capabilities that improve testability, observability, automation, and release confidence including selection of tools.
• Scale automation coverage across functional, regression, integration, performance, and non-functional testing to reduce cycle time and dependency on manual testing.
• Embed Quality Engineering into cloud, digital, and modernization programs to ensure quality at scale.
• Establish enterprise quality governance covering planning, execution, defect management, release readiness, and post-release validation.
• Define and operationalize enterprise KPIs and dashboards (automation coverage, escaped defects, release health, cycle time, defect trends, etc.) to enable data-driven decision-making.
• Provide executive-level reporting on quality risks, readiness, trends, and remediation plans.
• Ensure regulatory, compliance, and audit requirements are supported through traceability, reporting, and controlled quality processes.
• Align quality priorities with business risk, customer impact, and portfolio objectives.
• Lead and develop global Quality Engineering teams across onshore, nearshore, and offshore locations.
• Define clear accountability through operating models and RACI, enabling managers and leads to own delivery while the Director focuses on strategy and transformation.
• Mentor and grow future Quality Engineering leaders and foster a culture of high performance, ownership, and continuous improvement.
• Own Quality Engineering financial strategy including budgets, forecasts, vendor partnerships, contracts, and SOWs ensuring value, scalability, quality outcomes, and alignment with enterprise goals.
What we are looking for as a Director of Quality Engineering:
• At least 15 years of experience in Quality Assurance / Quality Engineering with 10 years of leading Quality Engineering teams on large enterprise transformation (P&C insurance or financial services preferred).
• Successful history of driving modernization of testing frameworks and practices in Financial Services preferably across Personal and Commercial Lines Insurance.
• Hand-on experience with Playwright, Selenium, JMeter, Gatling, LoadRunner and other cloud‑based performance testing tools.
• Proven leadership in building automation frameworks preferably around Guidewire Insurance Suite.
• Experience converting high-value regression and smoke tests from manual to automated suites, prioritizing risk and ROI, and integrating them into CI/CD.
• Experience in modernizing enterprise testing practices through APIs, events, microservices, and data platforms, ideally within Guidewire Insurance Suite, and crafting Quality Engineering strategies that cover both the core and connected digital ecosystem.
• Strong background in leading geographically spread Quality Engineering teams and external partners, ensuring efficiency and accountability through structured RACI models.
• Strong leadership, stakeholder management, communication skills — able to liaise between various departments effectively.
• Strong analytical, problem-solving skills and attention to detail.
• Proven experience of managing multiple priorities in a fast-paced environment.
• Ability to perform well and professionally in a demanding, high performance IT organization.
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
- The California Fair Chance Act
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Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
***REQUIRED to be located in, or willing to relocate to the greater Orlando area
***REQUIRED to have tradeshow and/or direct event related experience
_________________________________________________________________________________________
Job Title: Exhibits Account Executive
Reports To: Director of Client Management
AGS is looking for a dynamic person with excellent multi-tasking and interpersonal skills to fill the role of Account Executive for Custom Exhibits within a fast-growing trade show and events company. This specific role will be a Junior Level Account Executive that will focus on a small book of business and assist the Senior Account Executive on larger projects nationwide.
This person must be a self-starter, client focused and able to work well with multiple departments and teams. They should be able to effectively balance a client’s needs while managing strong budget and financial targets. Employees should be comfortable in a fast-paced and goal-oriented sales role as well.
This is a position which coordinates and participates in all aspects of the Exhibitor Custom display service process, including design, client order management, report distribution and project related service coordination. A team-oriented position: this individual will need to be able to support multiple exhibits projects over multiple events in the areas of customer engagement and cost management.
Primary Responsibilities
Exhibits Account Manager
- Act a primary point of contact and creative counterpart to Exhibitors assisting in design & build out of Custom Exhibits as part of a team working on AGS Display Solutions offering
- Develop and write proposals to secure business
- Able to multi-task, addressing simultaneous project/event assignments, including pre and post-project problem resolution
- Effectively work with custom display and exhibit partners to obtain bids, supply work orders and direct project as necessary
- Processes orders, prepares correspondence
- Fulfills customer needs to ensure customer satisfaction.
- Communicates clearly and concisely making every effort to listen and understand the customers’ needs and can properly channel that into action
- Works closely with supervisor/manager and sales team to obtain customer response protocols, problem resolution steps and per-project goals.
- Visit sites and make walkthroughs to ensure accurate project completion.
- Capability of leading on-site production crews or within an office team.
- Oversee installation or delivery of exhibit on-site
- Other assigned projects that maybe necessitated by business
Essential Skills and Responsibilities: (in no specific order)
- Has intermediate knowledge of commonly used concepts, practices, and procedures within the trade show and events industry.
- Execute in a timely manner communications to customers both requested and scheduled including open invoicing, estimates and other project related paperwork or details.
- Responsible for pre & post-show production follow up to ensure future quality control or to secure business with existing exhibits clients.
- Coordinate on-site service needs for exhibits through established methods of paperwork processing and customer order acquisition/execution.
- Act as liaison for all AGS services for exhibits client
- Assist in the coordination of project logistics such as shipping and similar 3rd party services.
- Perform other assigned duties as necessary to manage the department
Work Hours
General office hours are 8 AM to 5 PM, Monday through Friday. However, this position requires flexibility relative to a wide range of scheduled productions/events.
Availability to work evenings and weekends will be required to coordinate business.
Travel Requirements: ~25% +/-
Education and/or Experience:
- Experience in the trade shows or events industry.
- Four-year college bachelor’s degree at a minimum, as well as 3 to 5+ years of related work experience; A combination of education and work experience maybe used in lieu of college degree.
- Advance certifications within the events industry a plus, but not required.
Mathematical/Computer Skills:
- General math
- Must be able to type all correspondence and have at least “intermediate” knowledge of Microsoft Word, Outlook, Publisher, Power Point and Excel.
- Has experience in CRM or similar customer relationship management software
- Must be capable of learning company specific software/programs.
Language Skills: English
Physical Demands: Ability to lift a thirty-pound box and/or general office equipment for operational management.
Job Type: Full-time
Benefits:
● 3% Retirement match after 1 full year of service
● Dental insurance
● Health insurance
● Vision insurance
● Paid Time Off / Paid Holidays
● Remote Work Available up to 2 days a week after probation period
Schedule:
● Monday to Friday
● Weekend availability as needed for shows and travel
Supplemental pay types:
● Commission pay
Compensation:
● Base Staring at $50 ,000 based on experience.
● No Cap on Annual Commissions which start at 2%
We are excited to present an opportunity for a Director of Patient Safety and Quality at Kaweah Health, a publicly owned, community healthcare organization in Visalia, California. With over 5,000 employees and an eight-campus healthcare district encompassing 613 beds, Kaweah Health delivers comprehensive health services across a broad continuum of care. Our culture is deeply rooted in responsibility and accountability, emphasizing ownership from our team members. We serve a region with significant needs, making the rewards of contributing to our mission even greater.
Company Overview: Kaweah Health is dedicated to providing state-of-the-art medicine and high-quality preventive services, focusing on making a tangible difference in the health of our patients, loved ones, and community. Dr. Stefanacci, your direct report, fosters a supportive environment with minimal interference.
Position Overview: The Director of Quality orchestrates and influences the work of others to enhance Kaweah Health's mission, vision, and strategic priorities. This high-level leadership role holds accountability for safety and the necessary infrastructures to meet patient and family expectations. You will be instrumental in setting and executing strategies related to quality, patient safety, and regulatory compliance for a billion-dollar health system, impacting a large patient population in the Central Valley.
Primary Responsibilities: The Director of Quality will be responsible for quality, patient safety, and regulatory compliance. This involves collaborating with Dr. Stefanacci CMO/CQO, to set priorities and strategies, and then executing these plans effectively.
The role supports performance improvement activities throughout the organization, providing essential project management, performance improvement, and data analytics support. You will also be responsible for presenting to the CEO, executive team, and the board, and overseeing the quality of care for our extensive patient population.
This position designs and orchestrates the implementation of Quality and Patient Safety Plans, identifies and implements appropriate methods and tools for quality and patient safety, and participates in case review committees to address sentinel events and significant near misses. You will also provide resources for measurement and evaluation, collaborate with medical staff leaders on quality and patient safety systems, and develop a skilled department staff.
Coordinating all Joint Commission accreditation surveys and preparations is a key responsibility, as is identifying and implementing strategies for safety culture improvement and providing professional development opportunities.
Key Qualifications and Skills: We are seeking a candidate with 10 or so years of experience in quality-related roles within a hospital or health system, with at least 5 years of experience as a leader of a department or quality team. Expertise in performance improvement and experience managing people and a department are essential. The ideal candidate will have a proven track record of responsibility for strategic initiatives with demonstrated positive outcomes, showcasing an impact on strategic priorities with measurable results.
Strong collaboration skills are crucial for engaging teams and physicians. A passion for quality and patient safety, coupled with resilience, is highly valued due to the challenges inherent in this role. Required certifications include a current license in a relevant clinical discipline and a Certified Professional in Health Care Quality (CPHQ). Formal training in project management or performance improvement, such as Black Belt or Six Sigma certification, is also required. A Bachelor's degree in Health Care Administration, Nursing, or a relevant clinical discipline with additional training in Quality and Patient Safety is necessary, with a Master's degree preferred.
Team and Reporting Structure: This role reports directly to Dr. Stefanacci, who is the Chief Medical Officer and Chief Quality Officer. The Director of Quality will lead a diverse team comprising a quality team (manager + 5 individuals), an accreditation team (manager + 2 individuals), two data analytics specialists, two project management and performance improvement specialists, a patient safety program manager, and individuals overseeing stroke, sepsis, and clinical practice guidelines programs.
Collaboration is essential with the CEO, executive team, board members, and various internal teams, including Infection Prevention, Quality, Accreditation, Data Analytics, Project Management, Patient Safety, Stroke, Sepsis, and Clinical Practice Guidelines, as well as with physicians.
Key Priorities in the First Six Months: The top priorities for the first six months include demonstrating a measurable impact on strategic priorities by articulating them, establishing benchmarks, and achieving measurable outcomes. You will also support performance improvement activities across the organization, providing essential project management, performance improvement, and data analytics support.
Challenges and Opportunities: This role presents exciting opportunities to be in a leadership position with significant responsibility for setting quality and patient safety strategy for a billion-dollar health system, with direct contact with the executive team and board. You will have the chance to impact healthcare for a very large patient population in the Central Valley. Challenges include engaging teams outside of quality to collaborate on performance improvement and gaining active physician participation.
Candidate Profile: We are looking for individuals with a passion for quality and patient safety, and strong resilience to navigate barriers and roadblocks. Experience at a director level in a hospital or health system quality program, expertise in performance improvement, and experience managing a department or quality team are highly advantageous.
A clinical background is considered very helpful. Candidates should demonstrate ownership and responsibility for programs with measurable outcomes, beyond just achieving high ratings. Experience and responsibility for regulatory and accreditation are also necessary.
Candidates who thrive in community-based organizations with limited support are encouraged to apply.
We are actively seeking to fill this critical position and encourage you to apply if you meet these qualifications and are passionate about making a significant impact on healthcare quality and patient safety.
Mike Duggan is running the search, if you would like to learn more he can be reached at 72 or
Immediate need for a talented Compliance Specialist II (Manufacturing/Quality). This is a 12 Months contract opportunity with long-term potential and is located in Northborough, MA , USA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job Diva ID: 26-08294
Pay Range: $33 - $43/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Support department Quality Management System (Change Control, Deviations, CAPA)
- Main Accountabilities- Ensuring that activities within scope are conducted in compliance with applicable regulatory requirements
- Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
- Perform finished product inspections according to standards, specifications established timelines
- Perform AQL inspections according to standards, specifications established timelines
- Trend AQL failures according to standards, specifications established timelines
- Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
- Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelines
- Manage / perform annual inspection of retention samples
- Support creation of new material and product specifications
- Perform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
- Support department Quality Management System (Change Control, Deviations, CAPA)
- Support department documentation archival system
- Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
- Managing / escalating and resolving quality-related issues in a timely and effective manner
- Support the monitoring and analyzing of quality performance metrics, implementing corrective actions as needed
- Support root cause analysis investigations for quality incidents and implementing preventive measures
- Support quality walkthroughs
- Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focus
- Support risk management strategies to mitigate potential quality issues
- Fostering a culture of quality and continuous improvement across the organization
- Request corrections when GMP rules are not respected
- Prioritize quality and compliance objectives
- Request quality improvement initiatives and strategies
- Identify discrepancies and corrective/preventive actions that need to be taken
- Escalate to upper management any failure in GMP execution on shopfloor
- Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures
- Advise on how to present a topic and answer specific questions
- Advise on risk management strategies and plans
- Advise on initiatives to promote a quality-focused culture
Key Requirements and Technology Experience:
- Key skills: - Experience with inspecting finished goods and product
- Quality Shop floor experience
- Fully onsite position Possibility of extension Open to candidates willing to relocate at their own expense
- Top candidates, references will be requested Free parking onsite
- Bachelors degree (Masters and PHD's will be accepted)
- 3 Year experience in related role (more experience the better)
- Quality Shop floor experience, quality assurance review experience
- Experience with inspecting finished goods and product
- Previous pharma and biotech experience / GMP (strongly preferred)
- Change Control, Deviations, CAPA (strongly preferred) • SAP, Veeva
- Minimum 3 years of related experience
- Minimum Education: Bachelors degree
Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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Job Title: QA Consultant (GxP)
Location: San Diego, CA (On-site)
Position Type: Contract / Consultant
Department: Quality Assurance
Reports To: Site Quality Head / Director, QA
Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed
About Us
Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.
Position Summary
The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.
You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.
Key Responsibilities
Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.
Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.
Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.
Operate and support legacy Quality systems during the transition to new platforms.
Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.
Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).
Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.
Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).
Support continuous improvement efforts for events within EDMS and LMS.
Work with document owners to ensure timely periodic review of procedures.
Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.
Generate and trend quality metrics, communicating findings to leadership.
Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.
Review and approve paper-based quality documentation and electronic quality records.
Promote a culture of quality, teamwork, and accountability with a patient-first mindset.
Align daily activities with department goals and company values.
Ability to lift up to 20 pounds as needed.
Qualifications
Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).
Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).
Technical Skills:
Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.
Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.
Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
Competencies:
Exceptional written and verbal communication skills.
Strong attention to detail and ability to manage multiple projects simultaneously.
Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.
Experience developing training materials and delivering training to employees.
Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.
Job Title:Director, Quality Allergy Business Unit
FLSA Category (US Only):Exempt
Business Unit : ABU
Function : Quality
Country :USA
Work Location : Spokane, WA
Reporting Manager:Vice President, Quality
Team Size 50+
Direct Reports : 2
2. PURPOSE OF THE JOB:
The Director of the Quality Unit for the Allergy Business Unit is responsible for ensuring that the Quality Unit maintains standards expected by regulatory authorities, provides guidance to all Allergy Business Unit departments on procedures for meeting regulations, and promotes and enforces the expectations of the company for compliance. This position oversees the Quality Assurance and Quality Control areas specific to the Allergy Business Unit, in alignment with the Vice President of Quality and the corporate Quality initiatives. This position will work and partner with the leadership team of Allergy Business, including the CEO of Allergy Business, in implementing and driving quality structure.
3. KEY ACCOUNTABILITIES:
Responsibilities -
- Establish strategies and work plans to promote Compliance, Quality Culture and standards for aseptic processing conditions in the Allergy Business Unit, and overall Contamination Control Strategies. Ensuring the alignment of the Allergy Business unit with the overall CCS strategy for the site .
- Establish strategies and work plans to improve Quality Metrics and reduce areas of known risk from a compliance perspective.
- Establish a Data Governance team, metrics and dashboards focused on closing the site gaps in this area and sustaining compliance related to Data Governance.
- Promote and maintain the position and standards of Quality and Compliance matters to external clients, internal clients and regulators.
- Bring forth and establish overall quality standards with other members of management, including contamination control strategies and supporting documentation compliant with Annex 1.
- Establish standards for the disposition of finished product
- Maintain product quality by enforcing quality assurance policies and procedures and government requirements
- Review product and process quality reports by collecting, analyzing, and summarizing information and trends.
- Transfer knowledge and understanding of compliance concerns, history and mitigation plans through documentation of this knowledge, trainings, etc.
- Complete quality assurance operational requirements by scheduling and assigning employees
- Maintain quality assurance staff by recruiting, selecting, orienting, and training employees.
- Maintain quality assurance staff job results by coaching, counseling, and disciplining employees; planning, monitoring, and appraising job results.
- Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
- Prepare the Quality Unit budget for the Allergy Business Unit; scheduling expenditures; analyzing variances; initiating corrective actions.
- Contribute to team effort by accomplishing related results as needed
4. KEY INTERFACES
External Interfaces FDA Auditors
Internal Interfaces All functional areas
5. EDUCATION & EXPERIENCE
Education Qualification(Highest) Bachelor of Sciences, emphasis on Scientific discipline
Experience Required:
- 15 years related experience.
- Managerial Experience required: Management experience and demonstrated ability to work with personnel at all levels of the organization.
- Minimum 10 years experience managing quality functions in a parenteral manufacturing facility required.
- FDA Regulated Industry Experience: Position is required to be an expert in the application and interpretation of FDA and other regulatory agency regulations.
- Working knowledge of EU guidance requirements and Annex 1
6. SKILLS REQUIRED:
Skills
Description
Proficiency Level
Functional Skills
- Microsoft Word
- Microsoft Excel
- Microsoft PowerPoint
Behavioral Skills
- Interpersonal skills are required so the position can effectively work with and influence staff at all levels.
- Position will be in direct contact with clients and regulatory agency personnel and must be able to communicate differences of opinion in a positive and constructive manner.
- Position must be able to manage conflicts and influence outcomes.
- General Awareness: Knows the fundamental or general understanding of concepts.
- Working Knowledge: Has broad / working knowledge of the subject. Uses concept daily.
- Functional Expert: Candidate is certified functional expert with strong knowledge on concepts.
Mastery: Candidate is subject matter expert and has command over the subject/ concepts.
7. WORKING ENVIRONMENT (USA) :
Physical
Vision Requirements:
- 14/14 Corrected Near-Point
- Pass Color Deficiency Test
- Other Physical requirements:
- Exposure to Allergens
- Working in Aseptic Areas
- Prolonged Sitting
Environmental
- Managing conflict and influencing outcomes
Immediate need for a talented Quality Assurance Associate III. This is a 06+months contract opportunity with long-term potential and is locatedis located in Framingham, MA(Onsite). Please review the job description below and contact me ASAP if you are interested.
Job Diva ID: 26-09060
Pay Range: $50 - $57/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities: -
- The Third Party Management Specialist will oversee Third Party Quality operations for the MA BioCampus, ensuring excellence in quality standards and regulatory compliance across external partnerships.
- This role requires leading Supplier Change Notification (SCN) processes, managing third party quality event investigations, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, and Manufacturing departments to resolve compliance issues.
- The ideal candidate will have a Bachelor's degree or equivalent experience in Supplier Quality, minimum 6 years of Quality/Operations experience in a biotech/pharmaceutical cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems, and strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia).
- This position reports to the Head of Quality Third Party and requires the ability to gown and enter manufacturing
Key Requirements and Technology Experience:
- Key skills: Must have bachelor’s degree + 6 years of applicable experience
- Manager is open to all levels of experience Experience communicating with 3rd parties, understanding of 3rd party relations with impact QMS, quality agreements.
- Vendor pass, quality agreements, supplier change notification
- Previous experience with Veeva, quality agreements, supplier compliance, supplier change notifications preferred, SAP
- The Third Party Management Specialist will oversee
- Third Party Quality operations for the MA BioCampus, ensuring excellence in quality standards and regulatory compliance across external partnerships.
- This role requires leading Supplier Change Notification (SCN) processes, managing third party quality event investigations, supporting quality agreement programs including periodic reviews and documentation, and collaborating cross-functionally with QC, Facilities, and Manufacturing departments to resolve compliance issues.
- The ideal candidate will have a Bachelor's degree or equivalent experience in Supplier Quality, minimum 6 years of Quality/Operations experience in a biotech/pharmaceutical cGMP manufacturing environment within an FDA-regulated industry, proficiency in Veeva quality management systems, and strong knowledge of global pharmaceutical regulations (US, EU, Canada, Japan, Australia).
- This position reports to the Head of Quality Third Party and requires the ability to gown and enter manufacturing
Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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Job Details:
Global Pharmaceutical Company
QA Shop Floor - 3rd Shift
Fort Washington, PA - Onsite
Long Term, Ongoing Contract
Pay rate $25-30/hr
QA Shop Floor - 3rd shift
Must be able to work four 10 hour days, Sun to Wed 9:30pmEST to 8:00AMEST or
Wed to Sat: 9:30pmEST to 8:00AMEST
Responsible for maintaining quality records, assisting with corrective action plans, and supporting quality system improvements. You will collect and organize data, prepare reports, and ensure inspection readiness while addressing routine quality inquiries.
Key Responsibilities
Collaborate with cross-functional teams to implement innovative quality assurance protocols on the shop floor, ensuring seamless production flow and minimal defects.
Utilize data-driven insights to proactively identify potential quality issues and develop creative solutions to enhance product reliability.
Engage in hands-on inspection of products, applying a keen eye for detail to uphold stringent quality standards.
Performs batch records review and cleaning records review to ensure product availability.
Support work orders review and confirm area cleanliness after maintenance interventions.
Performs area walkthroughs to ensure audit readiness at all times.
Contribute to continuous improvement initiatives by suggesting and piloting novel QA methodologies tailored to dynamic manufacturing environments.
Document and communicate quality findings through clear, concise reports that facilitate swift decision-making and process optimization.
Maintain accurate and timely quality records related to product inspections, nonconformance, and project outcomes.
Assist in documenting, monitoring, and following up on corrective and preventive action plans to ensure their effective implementation and closure.
Respond to routine inquiries regarding technology transfer and improvements in manufacturing processes.
Collect, organize, and analyze data to prepare detailed reports for assigned quality processes.
Document and implement improvements to quality systems and standard operating procedures, including maintaining SOPs for interactions with contract manufacturers.
Gather and maintain documentation required for audits and inspections to ensure inspection readiness.
Support special quality projects and contribute to continuous quality improvement initiatives.
Required Qualifications
Bachelor’s degree or equivalent qualification in Engineering, Quality Management, Science or a related field demonstrating foundational technical knowledge.
2 years of practical experience or internships in quality assurance, manufacturing, or related operational environments.
Strong attention to detail and ability to maintain accurate documentation.
Basic understanding of investigations and automation processes.
Ability to collect, organize, and analyze data effectively.
Good communication skills to respond to routine technical inquiries.
Ability to work independently.
Ability to work night shifts and weekends.
Desired Qualifications
Strong analytical mindset with the ability to interpret complex data and translate it into actionable quality improvements.
Excellent communication skills to effectively collaborate with diverse teams and articulate quality concerns innovatively.
Familiarity with quality systems, audits, and inspection readiness.
Proactive learner with a passion for adopting emerging QA technologies and methodologies to drive shop floor excellence.
Proactive approach to supporting special quality projects and continuous improvement.
The Legacy nursing philosophy focuses on patients and their families. Our nurses embody this philosophy in everything they do, as advocates, communicators, problem-solvers and caregivers. Their expertise is sought after and respected by our health care team. In short, they are the face of wellness at Legacy. Does this sound like an environment in which you could thrive? If so, we invite you to consider this opportunity.
Responsibilities:The Nursing Practice and Quality Specialist serves as a clinical and operational expert in advancing nursing practice, patient safety, and quality outcomes. Guided by the NAHQ Healthcare Quality Competency Framework, this role supports the design, implementation, and evaluation of nursing practice standards, policies, and quality improvement initiatives that foster excellence in patient care, regulatory compliance, and continuous learning.
Critical Care Expertise:
- Must have knowledge of medical and surgical critical care and trauma processes and procedures
- Experience as a Neurological and Trauma nurse or nurse leader
- Experience with Code Blue and Rapid Response Teams
- Experience leading large multidisciplinary workgroups overseeing the system standards
Quality Leadership and Integration
- Champion a culture of quality and safety across Legacy Health through education, data transparency, and staff engagement.
- Collaborate with nurse leaders and providers to align nursing goals with organizational quality and strategic priorities.
- Serve as a resource for evidence-based practice
- Leads providers, managers and staff in implementation, compliance, and evaluation of clinical standards and evidence-based practice initiatives.
- Lead system-wide initiatives to reduce harm and improve clinical outcomes
Performance and Process Improvement
- Lead and facilitate interdisciplinary quality improvement (QI) projects using the PDSA methodology.
- Will represent a multi hospital view of system wide standardized processes and practices
- Analyze clinical processes, identify performance gaps, and implement improvement plans that enhance outcomes and efficiency.
- Monitor progress through data collection, dashboards, and feedback loops to ensure sustainability of improvements.
- Collaborates with providers, nurses and other clinical disciplines in the implementation, compliance, and evaluation of evidence-based clinical standards.
- Leads and participates in taskforces, committees or councils related to process improvement and provision of quality, evidence-based care.
- Uses Lean tools and principles to improve quality of workflow and patient care.
- Supports clinical practice initiatives to reduce harm, improve quality of care and meet clinical compliance requirements.
- Consults with Nursing Professional Development Specialists in the implementation of evidence-based practice.
- Promote a culture of safety, transparency, and continuous learning throughout the organization.
Patient Safety and Regulatory Readiness
- Coordinate safety initiatives, root cause analyses, and failure mode and effects analyses (FMEAs).
- Ensure nursing practices meet current standards, accreditation requirements, and regulatory expectations (e.g., The Joint Commission, CMS, state boards).
- Collaborate with leaders and frontline staff to implement corrective action plans and sustain compliance.
Health Data Analytics and Reporting
- Partner with data analysts to transform complex data into actionable insights for nurse leaders, providers, and staff.
- Support data-driven decision-making through accurate, timely performance measurement and reporting.
Population Health and Care Coordination
- Integrate population health principles into nursing practice to reduce health disparities and improve outcomes across the continuum.
- Contribute to initiatives that improve patient experience and outcomes across care settings.
Professional Practice Development
- Mentor and educate nurses on quality science, evidence-based practice, and outcomes measurement.
- Assists in developing and revising standards of care and practice to reflect national and regional standards, local practice trends, and current research
- Collaborates with nursing leadership, Legacy Research Institute, Nursing Professional Development Specialists and nursing staff in identifying opportunities for nursing clinical inquiry.
- Maintains currency in clinical practice and knowledge of professional standards of practice through participation in continuing education, community and professional activities, and committee membership.
Education:
- An academic degree in nursing is required (BSN or MSN/MN); master’s degree required.
Experience:
- Four years relevant clinical experience at a proficient to expert level of practice required with demonstrated involvement in quality or performance improvement.
- Preferred: Experience with regulatory/accreditation readiness, patient safety, and data analytics.
Skills:
- Strong knowledge of healthcare quality improvement principles and regulatory standards.
- Ability to work effectively in teams and independently.
- Excellent analytical, project management, organizational and facilitation skills.
- Ability to work in a stressful environment and take appropriate action.
- Excellent verbal and written communication skills including the ability to effectively communicate with staff, patients, and external stakeholders.
- Ability to influence without direct authority and build collaborative partnerships across disciplines.
- Proficiency in data visualization, report generation, and clinical information systems.
- Commitment to continuous learning and professional development in quality and safety science.
- Current applicable state RN license required.
- Certified Professional in Healthcare Quality (CPHQ) (or equivalent) upon hire or intent to obtain within 1 year.
Our Legacy is good for health for Our People, Our Patients, Our Communities, Our World. Above all, we will do the right thing.
If you are passionate about our mission and believe you can contribute to our team, we encourage you to apply—even if you don't meet every qualification listed. We are committed to fostering an inclusive environment where everyone can grow and succeed.
Legacy Health is an equal opportunity employer and prohibits unlawful discrimination and harassment of any type and affords equal employment opportunities to employees and applicants without regard to race, color, religion or creed, citizenship status, sex, sexual orientation, gender identity, pregnancy, age, national origin, disability status, genetic information, veteran status, or any other characteristic protected by law.
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