Manager Quality Assurance Compliance
About The Position
The Manager, Quality Assurance Compliance is a key member of the Quality organization, responsible for ensuring that all operations (Solid Orals as well as sterile manufacturing and aseptic filling operations), systems, and suppliers supporting the CDMO site comply with applicable US FDA (21 CFR Parts 210, 211, and 820), EU GMP, ICH Q-series, and ISO (9001/13485) requirements, as well as internal quality policies and client expectations. This role supports and executes the site’s regulatory compliance, internal audit, and supplier qualification programs, ensuring robust governance of cGMP systems and continuous readiness for regulatory and client inspections. The position is also responsible for driving CAPA effectiveness, regulatory communication, and compliance risk mitigation strategies across the organization. The incumbent will serve as a key host and coordinator during client and regulatory audits, ensuring timely and effective closure of any findings and proactive mitigation of compliance risks. This is an on-site position based at our Whippany, NJ facility.
Requirements
- Strong organizational and project management skills with attention to detail.
- Analytical and critical-thinking capability with a risk-based mindset.
- Ability to multitask and prioritize in a dynamic, fast-paced CDMO environment.
- Demonstrated integrity, accountability, and leadership presence.
- Ability to sit or stand for extended periods and occasionally lift up to 30 lbs.
- On-site presence required to support audits and inspection readiness activities.
- Bachelor’s degree (B.Sc./B.Pharm) in a scientific or technical discipline such as Pharmacy, Chemistry, Biology, or related field.
- Minimum 5+ years of progressive experience in Quality Assurance, Quality Compliance, or Auditing within the pharmaceutical, biotechnology, or CDMO industry.
- Strong working knowledge of US FDA 21 CFR Parts 210, 211, 820, EU GMP Part I, ICH Q-series, ISO 9001/13485, and Data Integrity (ALCOA+) principles.
- Demonstrated experience in hosting regulatory inspections, managing audit programs, and responding to FDA/EMA observations.
- Experience with risk-based quality systems, supplier management, and CAPA effectiveness verification.
- Proficiency with Quality Management Systems (e.g., TrackWise, MasterControl) and Microsoft Office Suite.
- Excellent written, verbal, and interpersonal communication skills with the ability to collaborate effectively in a cross-functional and client-facing environment.
Nice To Haves
- Advanced degree or ASQ Certified Quality Auditor (CQA) or equivalent certification preferred.
Responsibilities
- Plan, schedule, and perform internal audits, supplier/vendor qualification audits, and contract service provider assessments to ensure compliance with applicable GMP and quality standards.
- Prepare and issue audit agendas, reports, and responses; ensure timely and effective closure of audit findings and CAPAs. Develop and maintain audit response templates, ensuring alignment with FDA expectations and clear traceability of CAPA actions.
- Conduct risk-based audit planning and vendor risk assessments, ensuring that quality agreements are established and maintained.
- Evaluate the GMP compliance status of third-party facilities and support vendor approval, monitoring, and requalification activities.
- Support and host client and regulatory audits (FDA, EMA, MHRA, Health Canada, etc.), including “war room” coordination, document review, and inspection readiness activities.
- Lead or support regulatory impact assessments related to process, product, or supplier changes and ensure appropriate quality oversight of change controls.
- Ensure quality agreements are established, current, and reflective of applicable regulatory responsibilities.
- Collaborate cross-functionally with Product Development, Supply Chain, Procurement, Warehouse, and Manufacturing to ensure compliance is built into daily operations.
- Monitor and report Quality and Compliance metrics (e.g., audit performance, CAPA timeliness, supplier qualification status).
- Support regulatory compliance for import/export activities, product release, and documentation control as applicable.
- Maintain and continuously improve the Quality Management System (QMS) to ensure alignment with evolving global regulatory expectations and client requirements.
- Conduct training and mentoring of internal staff on GMP compliance, data integrity, and audit readiness.
- Perform other duties or projects assigned to support corporate and site compliance objectives.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
