Senior Director - GMP Quality Assurance

POSITION SUMMARY

The Senior Director, GMP Quality is responsible for the global oversight and management of GMP Quality Assurance operations supporting development and commercial programs. The role manages multiple complex priorities, provides technical and compliance leadership, resolves quality issues, and collaborates cross-functionally with internal stakeholders and external partners to support product quality, regulatory compliance, and continuity of clinical and commercial supply.

The position primarily provides oversight of clinical and commercial Good Distribution Practice (GDP) activities, including compliance with applicable U.S., EU/UK, and other global GDP requirements including the U.S. DSCSA, serialization, track-and-trace, and exception management requirements. The Senior Director is accountable for the quality and timely delivery of activities within the role’s scope.

JOB FUNCTIONS/RESPONSIBILITIES

• Provide QA oversight of finished product (FP), from early development through commercialization.
• Provide QA oversight of clinical and commercial product distribution activities in accordance with applicable GDP requirements, DSCSA, serialization, track-and-trace, and exception management requirements as appropriate.
• Support the development and approval of commercial labeling, including prepress activities, proofreading of labeling artwork, and anti-counterfeiting activities.
• Perform lot disposition activities, including batch record review; review of in-process, release, and stability testing; and assessment of quality events associated with GMP products and processes.
• Provide QA oversight across the product development lifecycle, including drug substance (DS) and drug product (DP) from early development through commercialization.
• Review and approve protocols and reports related to technology transfer, process validation, method transfer, method qualification and validation, and expiry dating, as applicable.
• Lead quality-related discussions, investigations, risk assessments, and change controls to ensure potential product quality issues are appropriately evaluated, addressed, documented, and justified.
• Provide technical expertise and guidance for internal and external deviations, laboratory investigations, change controls, and related quality events; ensure appropriate tracking, follow-up, and timely resolution in collaboration with responsible functions and external partners.
• Author, review, and negotiate Quality Agreements with GxP vendors, intra-company sites, alliance partners, and investigator-sponsored trial (IST) partners, as applicable.
• Author, coordinate the preparation, review, approval, and timely completion of Annual Product Reviews/Product Quality Reviews (APR/PQRs), as applicable.
• Perform compliance gap assessments, identify appropriate remediation actions, and drive implementation to completion.
• Communicate manufacturing deficiencies and nonconformances to management and work with external partners to ensure timely and effective resolution.
• Review and support regulatory and quality documentation for submissions, including INDs, CTAs, IMPDs, NDAs, and MAAs, as applicable.
• Interface with regulatory authorities, host third-party GMP audits, and support CMO pre-approval inspections (PAIs) and other regulatory inspections, as needed.
• Champion continuous improvement by identifying, leading, and monitoring initiatives that enhance quality, compliance, and operational effectiveness.
• Be willing and able to travel up to 20%, including international travel.
• Perform other duties as assigned.

QUALIFICATIONS

Education /Experience:

• Bachelor’s degree in a scientific discipline required; advanced degree (MS or PhD) preferred.
• 15+ years of experience in the pharmaceutical or biotechnology industry, including 12+ years of experience in GMP Quality Assurance. Experience in clinical and/or commercial labeling and last-mile commercial operations is required.
• Strong knowledge of and demonstrated experience with applicable global GMP and GDP requirements, including FDA regulations, EU GMP (EudraLex Volume 4), ICH guidelines, and distribution requirements for clinical and commercial products.
• Demonstrated experience supporting product development from early-stage development through global commercialization.
• Strong knowledge of CMC development, process validation, technology transfer, and small-molecule manufacturing operations.
• Strong knowledge of method development, method validation, and method transfer
• Hands on QC experience a plus.
• Experience supporting regulatory submissions (e.g., IND, CTA, IMPD, NDA, MAA) and health authority inspections, including PAIs.
• Experience overseeing international CMOs, contract testing laboratories (CTLs), contract packaging organizations (CPOs), third-party logistics providers (3PLs), and distributors.
• Experience with global serialization, track-and-trace, and DSCSA exception management is preferred.
• Strong understanding of the global pharmaceutical supply chain and product lifecycle management.
• Demonstrated experience with inspection readiness and continuous improvement of quality and compliance processes.
• Excellent communication, collaboration, leadership, problem-solving, and risk management skills.

The salary range for this position is $280,000 to $300,000 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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