First Quality Jobs in Usa

The Director Quality Affairs is in charge of providing subject matter expertise on matters related to FDA regulatory compliance requirements, as well as leading the growth and responsibilities of the Quality Department. Responsible for maintaining the company’s Quality Management System’s (QMS). The Director represents the company in key stakeholder and strategy meetings on all quality matters related the company’s assets (development and manufacturing), including meetings with executive leadership, meetings with FDA and other regulators, and working with development and manufacturing partners. This role combines scientific, regulatory, and business knowledge to assure that products are developed within GXP compliance while meeting the company’s strategic goals.

Essential Duties and Responsibilities:

Quality

• Manages GXP quality activities.
• Builds on the company’s Quality Management System; formulates the company’s GMP, GLP and GCP compliance strategies and provides advice and support for clinical development programs.
• Oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, storage and distribution sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
• Oversee the QA reviews of GMP manufacturing and packaging batch records, product release and stability testing, validation reports, and essential clinical study documents.
• Assess all GMP compliance risks and develop and implement risk mitigation measures.
• Develops and implements standards, policies and procedures for GMP, GLP and GCP compliance.
• Partners with CMC, Clinical Development and Clinical Operations to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance.
• Participates in the evaluation and selection of contract manufacturing sites, analytical testing sites, storage and distribution, CROs and other service providers used to support the clinical development programs.

Operations

• As the company grows, build a strong quality team to meet the needs of the business.
• Manage quality vendors.
• Develop and mentor quality staff/personnel.

Supervisory Responsibilities:

• Yes, in the future

Competencies:

To perform the job successfully, an individual should demonstrate the following competencies:

• Over 10 years of progressive advancement within GMP, GLP and GCP in the pharmaceutical /biotech industry.
• A thorough understanding of the drug development process along with knowledge of the developing regulations and guidelines.
• Ability to speak and interact with a diverse group of individuals on technical and business topics.
• Familiar with current regulatory legislation, industry trends, and health care business practices in the global arena.
• Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization.
• Strong presentation, written and verbal communication skills; a clear communicator who can influence stakeholders effectively, both internally and externally.
• Proven ability to lead and manage complex global projects to successful completion.
• Flexibility/agility to respond to Renew’s evolving business needs.
• Strong ability to influence and gain credibility with both internal and external key stakeholders.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex Quality issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
• Ability to build collaborative relationships both internally and externally.
• Ability to inspire, motivate and develop regulatory and quality teams.
• Ability to prioritize and handle multiple projects simultaneously.
• Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with scientists, managers, peers, and staff.

Education and/or Experience:

• BS/BA degree or equivalent (background in life sciences preferred). Advanced degree preferred.
• 10 +yrs. of industry experience (biotech/pharma/ CRO) with at least 8 years of QA experience
• Experience in ANDA and NDA FDA inspections (sponsor, vendor and sites)
• Strong understanding of ICH, GMP, GCP and relevant regulatory requirements
• Strong operations and management skills with attention to detail
• Excellent communication skills and proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project

Equal opportunity employer

Quality Engineer

As a Quality Engineer, you will assist with the development of quality systems, procedures and controls to ensure that all medical products consistently meet performance and quality specifications in the Germantown Manufacturing facility. The Quality Engineer is a leader and strong technical resource who quickly and effectively resolves quality problems with internal and external customers and suppliers.

Below Are Additional Duties And Responsibilities

• Generates, communicates, and implements ideas and solutions.
• Demonstrates accuracy and thoroughness in completing tasks timely.
• Looks for ways to improve and promote quality.
• Monitor Corrective Action System (i.e. Customer Complaints, Supplier, Internal)
• Initiate and investigate Customer Complaints according to our internal procedure and standards.
• Record essential information on internal and/or customer-specific documentation, including updating customer portals.
• Perform investigations using Lean, Six Sigma, and statistical methods to support root cause analysis and corrective actions.
• Identify gaps and/or trends in systems or processes.
• Initiate and facilitate the Corrective/Preventative Action process using the appropriate quality tools and input from subject matter experts (SME) to implement sustainable solutions.
• Update Quality documents according to our Change Control procedures, as required.
• Verify corrective action effectiveness.
• Drive Non-Conformance Process
• Evaluate and investigate suspect non-conforming product identified by manufacturing and/or the Quality Lab.
• Initiate containment activities, as necessary, with Customer Service and Shipping Department.
• Recommend disposition of product based on thorough investigation and data-driven feedback.
• Initiate and assist Customer Service with Return Material Authorization (RMA) process.
• Develop re-inspection, sort, and/or rework instructions for Manufacturing Operators, as required.
• Collaborate with customer on issuing waiver or deviation documentation and obtain customer approval, as required.
• Maintain the Quality Management System (QMS).
• Understand ISO 13485 Quality management systems requirements.
• Ensure continuing compliance to both internal processes as well as requirements imposed by certification bodies, regulatory agencies, and specific customer requirements.
• Assist in internal, 2nd party, and 3rd party audits.
• Assist with responses and corrective actions for audit findings.
• Support Product Realization process
• Participate in design review, process planning, and failure mode analysis
• Provide input on evaluation of Key Product Characteristics.
• Provide input on gaging methods and equipment.
• Interpret customer requirements including complex blueprints and GD&T call-outs.
• Review and approve Engineering Change Notifications and Verifications
• Evaluate for feasibility and implement updates to customer requirements into associated product control plans, pFMEA, Inspection documentation and other related documents.
• Incorporate industry standard best practices.
• Incorporate lessons learned.
• Evaluate, submit and track Supplier Change Notices to customers and/or suppliers.
• Any other duties as assigned.
• Manufacturing point of contact for the review and disposition of product quality related questions.
• Approve Medical Device release for shipment, as required.
• Perform batch record reviews for medical device prior to release for shipment.
• Generate Certificate of Analysis, as required.
• Release product in ERP system based on customer and process requirements.
• Support Manufacturing process
• Train Manufacturing and Quality Control personnel on customer requirements, inspection techniques, lessons learned, and rework instructions.
• Manage product inspection and testing activities.
• Obtain customer approvals for all required changes based on Quality Agreements.
• Compile supporting measurement and process performance data, as necessary
• Assemble supporting documentation package and review for completeness and accuracy
• Review and approve production documentation updates according to our Engineering Change Order process.

Global Quality Director – Warren, MI

Our client is seeking a Global Quality Director to lead quality strategy across operations. This role is responsible for ensuring compliance, driving continuous improvement, and aligning quality performance with customer and business expectations.

Why work here?

This organization offers a stable operating environment with a strong emphasis on operational excellence and continuous improvement. The company provides a competitive compensation and benefits package, along with opportunities for long-term growth and leadership impact within the organization.

Responsibilities:

The Global Quality Director is responsible for overseeing all aspects of operations quality, including:

• Leading and developing the quality organization
• Establishing and maintaining quality systems, policies, and procedures
• Ensuring compliance with internal standards and customer requirements
• Driving corrective and preventive actions
• Overseeing root cause analysis and problem-solving activities
• Monitoring key quality metrics and initiating improvement actions as required
• Supporting audits and customer interactions related to quality performance
• Partnering with internal customers to drive continuous improvement
• Other duties as assigned

Experience:

• Bachelor’s degree in Engineering, Quality, or a related technical discipline
• 5+ years of experience in quality leadership roles

If you are interested in learning more, please apply to this posting.

A well-established, FDA-regulated pharmaceutical manufacturing organization is seeking a Director of Quality to lead all Quality Assurance and Quality Control operations at its U.S. production site. This is a high-impact leadership opportunity to own and govern the full cGMP Quality Management System across both liquid and solid dose manufacturing in a commercial environment.

This role is ideal for a seasoned pharmaceutical quality leader who wants true authority, autonomy, and executive partnership within a stable, vertically integrated manufacturing organization.

The Opportunity

You will serve as the final authority for batch record review and product release, overseeing the integrity of the entire quality system in compliance with 21 CFR 210/211. Reporting directly to executive leadership, you will ensure inspection readiness, sustained compliance, and operational excellence across QA and QC.

This is a hands-on leadership role where your decisions directly protect product quality, patient safety, and regulatory standing.

What You Will Own

• Design, implement, and maintain a fully compliant cGMP Quality Management System
• Final decision authority on batch record review and commercial product release
• Oversight of deviations, investigations, CAPAs, change control, and complaint handling
• Regulatory inspection leadership (PAI, routine, and for-cause)
• Governance of third-party contractors and laboratories
• Establishment and audit of procedures, specifications, and manufacturing controls
• Executive-level risk reporting and quality performance metrics

You will lead a team of approximately 25–30 quality professionals (QA and QC), including multiple managers and laboratory staff.

What We’re Looking For

• 10+ years of pharmaceutical manufacturing quality leadership experience
• Direct experience in commercial pharmaceutical production (not medical device or food)
• Deep expertise in 21 CFR 210/211 and FDA regulatory expectations
• Proven authority over final batch release decisions
• Experience leading FDA inspections and responding to regulatory observations
• Demonstrated oversight of deviations, CAPAs, investigations, and complaint systems
• Strong cross-functional leadership skills and executive communication ability
• Bachelor’s degree in Chemistry, Biology, or related discipline

This role requires someone who can operate independently, maintain regulatory integrity, and collaborate effectively with operations and scientific leadership.

About the Organization

• FDA-regulated manufacturing site operating since 1946
• Vertically integrated producer of liquid and solid dose medications
• One of the largest producers of liquid antacid products in the U.S.
• Approximately 100 employees
• 132,000-square-foot manufacturing facility
• Long-term ownership and stable operational history

The plant is located in Gulfport, Mississippi, approximately:

• 5 miles from the beach
• 1 hour from Mobile
• 1.5 hours from New Orleans
• Low cost of living with strong military and industrial presence in the region

Compensation & Benefits

• Base salary $120,000 – $150,000+ (flexible for the right candidate)
• Relocation support available
• PTO plus additional paid holidays
• Approximately 22 additional annual paid holiday closures
• Medical, Dental, Vision, Disability, and supplemental plans available

Interview Process

• Brief HR screen
• Executive virtual interview
• Onsite interview
• Offer

Position Summary

The Quality Control Manager is responsible for ensuring that all packaging and consumable products purchased and distributed by Maadho meet company quality standards, regulatory requirements, and customer expectations. This role will proactively identify, investigate, and resolve quality issues while implementing preventive systems to maintain product consistency and compliance.

The ideal candidate has strong experience in food-service packaging and consumables, with a deep understanding of manufacturing standards, materials, and quality assurance processes.

Key Responsibilities

Quality Assurance & Inspection Audits

• Develop, implement, and maintain quality control procedures for all incoming products and inventory.
• Inspect food-service packaging and consumable products (e.g., gloves, cups, containers, cutlery, paper goods, bags) to ensure compliance with company and regulatory standards.
• Establish product quality benchmarks and specifications for suppliers.

Supplier Quality Management

• Work closely with domestic and international suppliers to communicate quality expectations.
• Review and approve supplier specifications, certifications, and compliance documentation.
• Coordinate corrective action plans with vendors when quality issues arise.
• Conduct supplier performance evaluations and recommend improvements.

Issue Identification & Resolution

• Track recurring issues and proactively recommend systemic improvements.
• Investigate customer complaints and internal QC findings.
• Perform root cause analysis on defective or non-conforming products.
• Implement corrective and preventive actions (CAPA).
  

Qualifications Required

• 3–5+ years of quality control experience in food-service packaging and consumables.
• Strong knowledge of materials such as paper, plastics, compostables, foam, and food-contact packaging products.
• Knowledge of FDA food-contact regulations and relevant industry standards including ISO Management
• Experience working with manufacturers and suppliers on quality standards and compliance.
• Proven ability to conduct root cause analysis and implement corrective actions.
• Strong attention to detail and organizational skills.
• Excellent communication skills with the ability to manage supplier relationships.
• Proficiency in Microsoft Office (Excel, Word) and quality reporting systems.

Key Words: ACR, Amercareroyal, Karat Packaging, Injection Mold, Eco Products, Novolex, Pactiv, Paper Products,

Position Description:

The Quality Manager will lead and oversee the Quality function at the Morton Grove site, ensuring compliance with GMP regulations, global quality standards, and customer expectations. This role will manage a team of Quality professionals and work closely with cross-functional departments to support the delivery of high-quality clinical and commercial batches.

The ideal candidate brings strong leadership skills, a solid understanding of CDMO business dynamics, and hands-on experience with clinical GMP manufacturing environments.

Role & Responsibilities:

• Lead and manage the Quality Assurance and Quality Control teams at the site, as well as working with Global Regulatory Affairs for RA topics.
• Ensure compliance with GMP regulations, global quality standards, and customer requirements for API manufacturing.
• Oversee batch release activities, including review and approval of clinical and commercial GMP batches.
• Develop, implement, and maintain Quality Systems (deviations, CAPA, change control, investigations, audits, etc.) to ensure a state of continuous compliance and inspection readiness.
• Act as the primary quality contact for clients, regulatory authorities, and internal stakeholders for the site.
• Support regulatory inspections and client audits; ensure timely and effective closure of observations.
• Collaborate closely with Operations, Engineering, Regulatory Affairs, and Project Management to support manufacturing and technology transfer activities.
• Drive continuous improvement initiatives to enhance quality performance and operational efficiency.
• Manage and develop the Quality team through effective leadership, training, and performance management.
• Contribute to the site’s strategic planning as part of the site leadership team.

Experience & Requirements:

• Bachelor’s or master’s degree in chemistry, Pharmacy, Chemical Engineering, or related field.
• Proven experience in a CDMO environment, working with multiple customers and projects.
• Strong experience with clinical GMP batch manufacturing and release.
• Previous experience managing and developing teams.
• In-depth knowledge of ICH guidelines, GMP regulations (e.g., EU GMP, US FDA), and regulatory expectations.
• Excellent communication skills and ability to interact effectively with internal and external stakeholders.
• Strong problem-solving and decision-making skills
• Minimum 5 years of experience in Quality roles within the pharmaceutical or chemical API industry.

Join the MEPPI Team!

Mitsubishi Electric Power Products, Inc. (MEPPI) is seeking a Quality Assurance Engineer II - Manufacturing to plan, direct and support activities to assess and provide for root cause analysis and corrective action implementation for Transportation Systems Division (TSD) quality problems. Implement and maintain quality assurance programs and lead efforts with internal audits.

This position will report to the TSD Quality Assurance Section Manager and is an onsite position in Freedom, PA.

What You’ll Do:

• Participate in and/or lead supplier validation audits using product quality planning tools.
• Collaborate with suppliers to investigate quality problems, identify root causes of problems, develop correction action plans and implement improvements. Verify corrective actions are implemented and maintained.
• Serve as a quality assurance liaison to Japan. Learn and implement applicable Japanese techniques for quality assurance improvements.
• Participate in the development of new products or modifications of existing products to meet customer requirements.
• Participate in and/or lead internal audits. Work with all departments to help close audit findings in an effective and timely manner.
• Coordinate continued evaluation of procedures and documentation throughout TSD. Verify for completeness, accuracy and lack of redundancy.
• Facilitate in-house quality assurance and manufacturing improvement programs throughout TSD.
• Assure quality records are generated, retained, stored, protected and disposed of according to TSD and Company policies.

What You’ll Bring:

• Bachelor’s Degree in Engineering or related technical field with 3-5 years of experience in quality control and/or assurance function, or equivalent education and experience.
• Advanced knowledge of QA and manufacturing improvement practices such as Lean Six Sigma and Black Belt and an understanding of the underlying philosophy.
• Advanced knowledge of quality techniques such as Statistical Process Control, Deming Methods, 5-Why, 8DS, etc.
• Advanced interpersonal communication and presentation skills required to communicate with customers, vendors and employees.
• Advanced analytical and problem-solving skills.
• Advanced computer skills with emphasis on MS Office products and MRP/ERP systems.

What’s in It for You:

Comprehensive Health Coverage:

• MEPPI pays up to 90% of the cost for medical, dental, and vision plans.

Retirement Plans:

• 401(k) match of up to 4%.

Generous Paid Time Off:

• Earn vacation after just 90 days, plus enjoy 12 paid holidays annually.

Career Growth:

• Access to professional development programs and educational assistance.

Employee Perks:

• On-site fitness center (Warrendale, PA), wellness program, profit sharing, and employee discounts.

Why MEPPI:

As a proud U.S. affiliate of Mitsubishi Electric, MEPPI powers critical infrastructure and rail transportation solutions across North America. We value collaboration, innovation, and people—because we know that our greatest asset is our team. Join us and help shape a future where talent and technology thrive

Equal Opportunity Employer:

MEPPI is committed to diversity and inclusion in the workplace. We welcome applicants from all backgrounds and ensure fair consideration for every candidate.

Notice to Agencies and Search Firms:

We do not accept unsolicited resumes from agencies. Submissions without signed agreements become the property of MEPPI, and no fees will be paid.

Applicants are considered for all positions without regard to race, color, religion, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, marital status, national origin, ancestry, age, physical or mental disability or (as defined by applicable law) medical condition or genetic information, military or veteran status or any other legally protected status.

Notice to Agency and Search Firm Representatives: Mitsubishi Electric Power Products, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Mitsubishi Electric Power Products, Inc. employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Mitsubishi Electric Power Products, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

About Made Scientific

Made Scientific is a leading US-based cell therapy contract development and manufacturing organization (CDMO) specializing in the development, manufacturing, and release of autologous and allogeneic cell therapy products for clinical-and-commercial supply. Made Scientific combines the agility and entrepreneurial spirit of a specialist CDMO with the global expertise and resources of GC Corporation of South Korea, a global leader in the pharmaceutical and biotechnology sectors.

Position Summary

The Director, Quality Systems is a hands-on leadership role responsible for leading the development, design, and maintenance of the Quality Management System (QMS). This role will oversee the implementation and continuous improvement of the QMS to maximize efficiency, effectiveness, and compliance with all applicable GxP regulations and client requirements and expectations.

Key Responsibilities

• Develop and maintain the Site Quality Management System and provide ongoing assessment of QMS effectiveness through Quality Management Review (QMR) and other established monitoring programs and processes.

• Identify, execute, and manage quality improvement initiatives to continually improve efficiency, effectiveness, and compliance with applicable cGMP regulations and client requirements.

• Support the development of company objectives and ensure Quality Plan initiatives are properly planned, prioritized, resourced, executed, and evaluated for effectiveness.

• Direct the Quality Management Review process, including oversight of analysis and reporting of Quality System performance metrics.

• Identify compliance gaps and improvement opportunities to inform the Site Quality Plan and inspection readiness strategies.

• Co-lead the Internal Audit program with the Head of Inspection Readiness, including oversight of audit schedules and ensuring appropriate follow-up in alignment with internal procedures, regulatory expectations, client requirements, and auditing best practices.

• Manage the CAPA system, ensuring root causes are clearly identified and addressed through robust corrective actions to prevent recurrence, and that actions are evaluated for effectiveness post-implementation.

• Establish and manage GMP training programs to ensure training requirements align with job functions and job descriptions.

• Collaborate with the Head of Inspection Readiness to coordinate activities related to regulatory and client inspections (announced or unannounced), including preparing documentation, identifying potential compliance gaps, and managing inspection logistics.

• Support post-inspection response activities, including drafting responses, coordinating updates, and ensuring follow-up actions are implemented within the QMS.

• Provide input into regulatory inspection responses to ensure systemic and comprehensive solutions address root causes and prevent recurrence.

Leadership & People Management

• Mentor and coach team members to continually develop and enhance their skills.

• Lead by demonstrating the company values of standing shoulder to shoulder, owning it always, breakthrough thinking, and competing where it counts.

• Foster a culture of accountability with progressive empowerment and ownership.

• Promote a culture that values innovation, continuous improvement, and personal accountability across the organization.

Required Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific discipline.

• 10–12 years of cGMP or Quality experience, including prior supervisory or team leadership experience; or a Master’s degree with 5–7 years of relevant experience.

• Experience hosting and managing regulatory and client inspections.

• Strong understanding of Quality Systems requirements and regulatory expectations.

• Excellent oral and written communication, listening, and problem-solving skills.

• In-depth knowledge of regulated activities, health authority expectations, GxP, and Quality Risk Management.

• Strong organizational awareness with significant experience working cross-functionally.

• Experience developing and executing large-scale organizational change initiatives, including change management strategies and planning.

• Demonstrated ability to understand complex processes and facilitate teams toward effective solutions.

• Ability to design and implement global business processes and policies with a strategic and enterprise mindset.

• Proven experience influencing stakeholders across a broad spectrum of GxP topics.

• Flexibility to support varying work schedules, including evenings, weekends, or holidays as needed.

Preferred Qualifications

• In-depth knowledge of cGMP regulations and the ability to apply them in compliance with U.S., EU, and global regulatory standards.

• Experience with cell and gene therapy manufacturing in clinical or commercial environments.

• Strong track record managing quality systems and training programs.

• Expertise in aseptic manufacturing processes.

• Demonstrated ability to foster collaboration, influence cross-functional teams, and drive cultural and operational improvements.

• Innovative mindset with the ability to adapt best practices within a fast-paced, growing organization.

Required Degree

• B.S. in a relevant scientific discipline (advanced degree preferred).

Physical Requirements

Ability to perform job functions in compliance with applicable standards, including productivity and attendance expectations. Must be flexible to work in various environments, including gowning for aseptic processing facilities, lifting up to 25 lbs., and performing physical tasks such as bending, standing, and working with cell-based products or chemicals.

About NYC Health + Hospitals

NYC Health + Hospitals is the largest public health care system in the nation. We are a network of 11 hospitals, trauma centers, neighborhood health centers, nursing homes, post-acute care centers, and correctional health services. We are a home care agency and a health plan, MetroPlus. Our health system provides essential services to 1.4 million New Yorkers every year in more than 70 locations across the city's five boroughs. Our diverse workforce of more than 42,000 employees are uniquely focused on empowering New Yorkers.

NYC Health + Hospitals/Correctional Health Services is one of the nation’s leading correctional health care systems in quality of and innovations to care, and access from pre-arraignment through compassionate release. In-jail services include medical, nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition to providing direct patient care in the jails, CHS leverages the resources of the nation’s largest municipal health care system to help discharged patients successfully return to their communities. CHS is also a pivotal partner in New York City’s criminal justice reform efforts.

Work Shifts

• 9:00 A.M – 9:00 P.M
• Various Location at Rikers Island

Duties & Responsibilities

Summary of position: (Position Description)

Reporting to the Chief of Medicine, the Director of Quality Initiatives will serve as a central point of supervision for quality initiatives with wide latitude to participate in programmatic quality improvement and quality assurance work across the CHS Medicine service. The Director of Quality Initiatives will function as a part of the medicine service and support initiatives to improve care across the service. The role will involve developing a deep understanding of workflows and operations of the CHS Medicine service and working across disciplines to coordinate quality initiatives, analyze data, and support presentations.

Responsibilities include: (Detailed Task)

• In coordination with CHS Medicine leadership and CHS IT Health Information unit, manage data and presentations for Medicine quality improvement committee (QIC) meetings.
• Maintenance and dissemination of monthly quality Improvement dashboard.
• Coordinate facility-based quality improvement meetings to provide direct feedback to Medicine service clinical staff.
• Coordinate with the Compliance and Health Information unit and Medicine service leadership to meet Medicine QIC and NYC H+H Quality Assurance Performance Improvement (QAPI) obligations.
• Track and support completion of Performance Improvement Projects that meet specific quality goals.
• Work with CHS Medicine leadership to share findings within CHS and externally where appropriate.
• Learn clinical and operational workflows of care delivery in the New York City jails in order to identify areas for focused improvement initiatives.
• Liaise between Medicine leadership, IT and other departments on new reports and initiatives.
• Collaborate in implementing new and revising existing quality improvement projects.
• Participate in other data projects and tasks as requested.
• Cross-cover Medicine Service central administrative team (including Medicine Special Assistant, Director of Medical Administration, and Director of Clinical Education) to meet service goals and support administrative needs of service leadership.

Minimum Qualifications

1. A Master’s degree from an accredited college or university in Public Administration, Public Health, Business Administration, or a related discipline, and one (1) year of full-time experience in an administrative capacity in business management systems, general administration, health care or medical/patient systems administration; or,

2. A Baccalaureate Degree from an accredited college or university in Public Administration, Public Health, Business Administration, or a related discipline, and two (2) years of full-time experience in an administrative capacity in business management systems, general administration, health care or medical/patient systems administration.

Department Preferences

• Master's Degree in Public Health, Master's Degree in Public Administration, or related degree with a concentration on quantitative and/or qualitative analysis.
• Experience working within correctional settings on academic, research, or data-driven projects.
• Strong data/statistical analysis and database management skills;
• Advanced knowledge of Windows and Microsoft Office Suite and familiarity with standard statistical software packages (SPSS, SAS, etc.);
• Interest in correctional healthcare;
• Excellent interpersonal communication skills and ability to work collaboratively with other disciplines, including DOC staff;
• Strong organizational, project management, and multitasking abilities.

Benefits

NYC Health and Hospitals offers a competitive benefits package that includes:

• Comprehensive Health Benefits for employees hired to work 20+ hrs. per week
• Retirement Savings and Pension Plans
• Paid Holidays and Vacation in accordance with employees' Collectively bargained contracts
• Loan Forgiveness Programs for eligible employees
• College tuition discounts and professional development opportunities
• College Savings Program
• Union Benefits for eligible titles
• Multiple employee discounts programs
• Commuter Benefits Programs

Director of Quality

The Director of Quality is responsible for building and leading a fit-for-purpose, phase-appropriate Quality Management System (QMS) for Halia Therapeutics. This role will oversee GxP quality activities, develop and enforce policies and SOPs that comply with US FDA, Australian TGA, EU EMA, Indian CDSCO, and UAE Ministry of Health regulations, manage vendor quality, and ensure audit readiness across the organization.

Key Responsibilities

·      Design, implement, and maintain a scalable, phase-appropriate Quality Management System (QMS).

·      Develop, maintain and enforce quality policies, SOPs, templates, and controlled documents.

·      Ensure GxP compliance across multi-national GCP, GLP, GMP, and other applicable areas. It may be implied under GCP: consider mentioning TMF oversight ensuring completeness/accuracy/integrity of TMF + clinical data; same for GLP, it may be implied: consider data integrity and equipment validation (Utah Lab)

·      Create and manage the company-wide training program, including role-based curricula and compliance tracking.

·      Lead vendor qualification, auditing and performance reviews for CROs, CMOs, labs, and other suppliers.

·      Develop and execute annual internal and external audit plans.

·      Ensure timely resolution of audit findings, deviations (including GDP-Good Documentation Practice), CAPAs, and change controls.

·      Support inspection readiness and host regulatory inspections as needed.

·      Establish quality metrics and dashboards for leadership reporting.

·      Manage QDs budget, collaborate w leadership embedding quality into company’s development strategy

·      Cross-functional collaboration (ClinOps, Reg Affairs, R&D, leadership)

·      Other duties as assigned

Qualifications – Required

·      Bachelor’s degree in Life Sciences, or related field.

·      10+ years of experience in pharmaceutical or biotech Quality roles.

·      Experience building or scaling a QMS in a small or growing company.

·      Strong knowledge of GxP regulations (GCP, GLP, GMP); global regulatory exposure

·      Demonstrated experience authoring SOPs and leading audits.

·      Strong communication and collaboration skills across cross-functional teams.

·      Proven experience to lead/mentor teams

Preferred Qualifications

Advanced degree (MS, PhD, PharmD).

Experience implementing an electronic QMS (eQMS).

Experience hosting regulatory inspections.

Quality certifications (e.g., ASQ, RAC).

Ths is an onsite position in Lehi, Utah and relocation assistance will not be available.

Salary Range $170,000 --$200,000