Director, GMP Quality Assurance Operations

POSITION SUMMARY

We are seeking an experienced Director, GMP Quality Assurance (QA) Operations to provide strategic and operational leadership in managing quality for outsourced manufacturing and testing operations, ensuring product quality, regulatory compliance, and reliable supply of clinical material. This role will be a key cross-functional partner, and will work closely with CMC, Supply Chain, Quality Control, and Regulatory teams to drive quality strategy, continuous improvement, and operational excellence.

Responsibilities:

• Manage and provide oversight of routine operations conducted by external partners, including CDMOs and testing labs
• Provide timely feedback for GMP quality events and escalate to management for aligned decisions, as appropriate.
• Ensure timely batch record review, product disposition, and compliance with regulatory requirements
• Develop and monitor partner performance metrics, risk assessments, and escalation pathways
• Collaborate with internal CMC, Regulatory, Quality Control, and Supply Chain teams to support technical transfers, process development, and regulatory submissions
• Serve as GMP SME for cross-functional initiatives to strengthen quality systems, enhance compliance, and drive operational efficiency
• Serve as a primary QA representative during regulatory inspections (FDA, EMA, and other global authorities), including hosting inspections, responding to questions, and managing commitments.
• Own inspection follow-up activities, including CAPA development, execution, and effectiveness verification.
• Champion a culture of quality and inspection readiness across internal and external operations

Qualifications:

• Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field
• 8+ years of progressive cGMP Quality Assurance experience supporting biologics manufacturing and analytical testing in a regulated environment, Person in Plant, and direct Inspection experience with domestic and international regulatory agencies
• Direct experience managing external partners/CDMOs and ensuring compliance from clinical supply through validation to commercial supply
• Strong knowledge of FDA, EMA, ROW CGMP regulations, and ICH guidance
• This is a hybrid on-site / remote work schedule, with 3 days on-site per week

The salary range for this position is $220,000 to $235,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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