Quality Assurance Manager
Pay range: 62-72/hr
*depending on exp
Position Summary
The Quality Assurance Manager – Clinical Packaging and Labeling is responsible for providing GMP Quality Assurance oversight of clinical packaging, labeling, and clinical finished goods operations supporting investigational drug development programs from early-phase development through late-phase clinical trials. This role ensures that clinical packaging and labeling activities performed by Contract Manufacturing Organizations (CMOs) comply with applicable GMP requirements, regulatory expectations, approved specifications, and company Quality Systems. The position provides quality oversight throughout the clinical supply lifecycle, including packaging and labeling documentation review, batch disposition support, quality event management, change control, temperature excursion assessments, and risk-based decision-making to ensure patient safety, product quality, data integrity, and continuity of clinical supply. The Quality Assurance Manager serves as a quality leader and subject matter expert for clinical packaging and labeling activities, driving quality excellence, process improvements, and risk-based decision-making across internal and external stakeholders. This position collaborates closely with Clinical Supply Chain, CMC, Regulatory Affairs, Clinical Operations, and external partners to resolve quality issues, support timely release of Investigational Medicinal Products (IMPs), and maintain inspection readiness.
Key Responsibilities
Clinical Packaging and Labeling Quality Oversight
* Provide GMP Quality Assurance oversight for clinical packaging and labeling operations conducted at external manufacturing and packaging facilities.
* Review and approve clinical packaging and labeling batch records, master batch records, label text and proofs, and supporting documentation, as applicable.
* Ensure packaging and labeling activities comply with approved protocols, clinical trial requirements, applicable regulatory requirements, and established quality procedures.
* Support qualification and ongoing oversight of clinical packaging and labeling vendors, including review of applicable quality documentation and assessment of operational readiness.
* Participate in vendor and internal meetings, quality discussions, CAPA activities, and continuous improvement initiatives to promote compliant and consistent execution of packaging and labeling processes.
* Provide quality guidance and leadership during clinical supply planning, packaging campaigns, and labeling strategy discussions.
Clinical Trial Material Release and Disposition
* Perform QA review and approval of documentation required to support disposition and release of Investigational Medicinal Products (IMPs) and associated clinical trial materials.
* Review executed batch records, certificates of analysis, applicable protocols, expiry documentation, and other records required to support material release.
* Assess quality documentation supporting expiry extensions, release restrictions, and other disposition-related decisions.
* Evaluate temperature excursions and other storage, transportation, or distribution events affecting clinical trial materials, including assessment of product quality, supporting stability data, and potential impact on clinical supply.
* Coordinate with Clinical Supply Chain and relevant stakeholders to resolve release issues and minimize potential disruptions to clinical trials.
* Support Qualified Person (QP) certification and release activities, where applicable, by ensuring the availability and adequacy of required quality documentation.
* Make timely, scientifically justified, risk-based disposition decisions while maintaining compliance with applicable GMP requirements.
Quality Systems and Compliance
* Manage and provide QA oversight of deviations, investigations, CAPAs, change controls, out-of-trend events, product complaints, and other quality events associated with clinical packaging, labeling, storage, and distribution activities.
* Lead or support investigations to identify root causes, assess potential product and patient impact, and establish appropriate corrective and preventive actions.
* Evaluate proposed changes to packaging processes, labeling components, vendors, and clinical supply operations to determine GMP, regulatory, and product quality implications.
* Perform documented product impact assessments and risk evaluations to support scientifically justified quality decisions.
* Establish and maintain release restrictions, quality holds, or other controls as necessary to prevent distribution or use of materials pending resolution of quality concerns.
* Ensure quality events and associated actions are documented, tracked, escalated, and closed within established timelines.
* Identify recurring quality issues, compliance gaps, and opportunities to strengthen quality systems and improve operational effectiveness.
External Vendor and Stakeholder Management
* Serve as the primary QA point of contact for assigned CMOs and other external service providers.
* Provide quality guidance on GMP expectations, documentation requirements, batch record discrepancies, labeling controls, and clinical trial material disposition.
* Partner with Clinical Supply Chain, CMC, Analytical Development, Regulatory Affairs, Clinical Operations, and other internal stakeholders to resolve quality issues and support clinical supply timelines.
* Monitor vendor quality performance, identify emerging risks, and escalate significant compliance, quality, or supply concerns to QA leadership.
* Support effective communication and coordination between internal stakeholders and external partners to facilitate timely and compliant execution of clinical supply activities.
Leadership and Continuous Improvement
* Serve as a quality leader and subject matter expert for clinical packaging, labeling, release, and disposition activities.
* Influence cross-functional teams and external partners to drive compliance, quality culture, and risk-based decision-making.
* Lead quality initiatives focused on strengthening documentation practices, vendor oversight, inspection readiness, and clinical supply processes.
* Mentor and provide guidance to colleagues and project teams on GMP requirements, quality systems, and best practices.
* Drive continuous improvement efforts to increase efficiency, enhance compliance, and reduce quality risks across clinical supply operations.
* Support departmental objectives, quality metrics, strategic initiatives, and inspection readiness activities.
Quality Documentation and Inspection Readiness
* Review, author, and/or approve applicable SOPs, work instructions, quality agreements, risk assessments, and other controlled quality documentation.
* Ensure clinical packaging and labeling documentation is complete, accurate, traceable, and maintained in accordance with applicable documentation and data integrity requirements.
* Support regulatory inspections and internal audits by ensuring relevant documentation is readily available and inspection ready.
* Maintain current knowledge of applicable GMP regulations, clinical trial requirements, and industry expectations related to Investigational Medicinal Products (IMPs), clinical packaging, labeling, and outsourced manufacturing operations.
* Recommend and implement process improvements that enhance compliance, documentation quality, vendor oversight, and clinical supply efficiency.
Qualifications and Experience
* Bachelor’s degree in a scientific discipline, pharmaceutical sciences, or a related field; equivalent relevant experience may be considered.
* Typically 7+ years of experience in Pharmaceutical Quality Assurance, Quality Operations, or a related GMP-regulated function, including demonstrated experience supporting clinical packaging and labeling operations.
* Demonstrated experience reviewing and approving clinical packaging and labeling batch records and supporting documentation.
* Experience supporting clinical trial material release, IMP disposition, expiry extension assessments, temperature excursion investigations, and release restriction decisions.
* Strong working knowledge of GMP requirements applicable to Investigational Medicinal Products (IMPs), clinical packaging and labeling, and outsourced manufacturing operations.
* Experience managing or providing QA oversight of deviations, investigations, CAPAs, change controls, and documented product impact assessments.
* Experience working with external CMOs and pharmaceutical service providers.
* Experience with vendor quality oversight, audits, quality agreements, and inspection readiness preferred.
* Familiarity with electronic quality management systems and document management platforms.
* Experience supporting early-phase clinical development programs and managing competing clinical supply priorities preferred.
Core Competencies
* Strong technical writing, documentation review, and risk assessment skills.
* Sound judgment and the ability to make timely, scientifically justified, risk-based quality decisions.
* Demonstrated leadership and influencing skills in a matrixed environment.
* Strong organizational and project management skills, with the ability to manage multiple priorities and time-sensitive clinical supply activities.
???????* Effective communication and collaboration skills with internal stakeholders and external partners. The role requires effective coordination with external manufacturing, packaging, labeling, storage, and distribution partners, as well as close collaboration with Clinical Supply Chain, CMC, Regulatory Affairs, Clinical Operations, and Quality. Periodic domestic travel may be required to support vendor oversight, on-site packaging and labeling activities, audits, inspections, and other quality initiatives.