Hybrid Details: Onsite 3 days per week.
Duration: 6 months to start.

Job Summary

This role provides GMP Quality Assurance oversight of clinical packaging, labeling, and clinical finished goods operations supporting investigational drug development programs from early-phase through late-phase clinical trials. It ensures packaging and labeling activities performed by contract manufacturing organizations comply with GMP requirements, regulatory expectations, and company quality systems, and covers the full clinical supply lifecycle - documentation review, batch disposition, quality events, change control, temperature excursion assessments, and risk-based decision-making. The Quality Assurance Manager acts as a quality leader and subject matter expert, collaborating closely with Clinical Supply Chain, CMC, Regulatory Affairs, and Clinical Operations to support timely release of investigational medicinal products and maintain inspection readiness.

Responsibilities

• Provide GMP Quality Assurance oversight for clinical packaging and labeling operations conducted at external manufacturing and packaging facilities, including review and approval of batch records, label text and proofs, and supporting documentation.
• Support qualification and ongoing oversight of clinical packaging and labeling vendors, including assessment of operational readiness.
• Review documentation supporting disposition and release of investigational medicinal products and clinical trial materials, including certificates of analysis, expiry documentation, and temperature excursion assessments.
• Manage QA oversight of deviations, investigations, CAPAs, change controls, out-of-trend events, and product complaints tied to clinical packaging, labeling, storage, and distribution.
• Serve as the primary QA point of contact for assigned contract manufacturing organizations, providing guidance on GMP expectations, documentation requirements, and batch record discrepancies.
• Partner with Clinical Supply Chain, CMC, Regulatory Affairs, and Clinical Operations to resolve quality issues and support clinical supply timelines.
• Author and/or approve SOPs, work instructions, quality agreements, and risk assessments, and support regulatory inspections and internal audits.
• Mentor colleagues on GMP requirements and quality systems, and drive continuous improvement in documentation practices, vendor oversight, and clinical supply processes.

Qualifications

• Bachelor's degree in a scientific discipline, pharmaceutical sciences, or a related field; equivalent relevant experience considered.
• 7+ years of experience in pharmaceutical Quality Assurance, Quality Operations, or a related GMP-regulated function, including 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, clinical packaging and labeling, and outsourced manufacturing operations.
• Experience managing or providing QA oversight of deviations, investigations, CAPAs, and change controls.
• Experience working with external contract manufacturing organizations and pharmaceutical service providers.

Preferred

• Experience with vendor quality oversight, audits, quality agreements, and inspection readiness.
• Familiarity with electronic quality management systems and document management platforms.
• Experience supporting early-phase clinical development programs and managing competing clinical supply priorities.

Talent Groups is an equal opportunity employer that values diversity and inclusion. All qualified applicants will receive consideration without regard to protected characteristics. The listed compensation range represents a good-faith estimate and may vary based on experience, skills, education, certifications, market conditions, client budget, and location, in accordance with applicable pay transparency laws.

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