Associate Director, GMP Quality Assurance

The Opportunity:

The Associate Director, GMP Quality Assurance will provide quality oversight and decision-making authority for development, technology transfe , manufacture, testing, and batch disposition of small molecule Drug Substance (DS) and Drug Product Intermediate (DPI). The role ensures GMP compliance, product quality, data integrity, and inspection readiness for late-stage clinical and commercial programs.

This role will be the primary Quality partner to Technical Operations, CMC, Regulatory, Supply Chain, Analytical Development, and external CDMOs, with end-to-end oversight of DS and DPI manufacturing, quality events, validation, release, and continuous improvement.

Key Responsibilities include:

• Provide QA oversight and disposition support for clinical and commercial small molecule DS and DPI batches, ensuring compliance with GMPs, regulatory filings, specifications, and internal standards.

• Review and approve master and executed batch records, specifications, methods, certificates of analysis, and release packages.

• Review and approve deviations, investigations, OOS/OOT results, change controls, CAPAs, and risk assessments affecting DS and DPI; ensure scientifically sound product-impact evaluations.

• Lead Quality Governance and operational meetings with CDMOs and contract laboratories to align on manufacturing readiness, issue escalation, release timelines, and performance.

• Provide QA oversight for technology transfer, scale-up, process validation/PPQ, cleaning validation, analytical method transfer, and continued process verification.

• Support CMC submissions, inspections, lifecycle changes, and health authority responses.

• Maintain inspection readiness and the GMP Quality System through SOPs, supplier qualification, metrics, and oversight of critical materials, CDMOs, and laboratories.

Required Skills, Experience and Education:

• A Bachelor's degree in a scientific or technical discipline is required.

• A minimum of 10+ years of progressive GMP Quality experience, including late-stage or commercial small molecule DS and/or DPI manufacturing.

• Quality oversight of CDMOs supporting technology transfer, validation/PPQ, manufacturing, testing, and batch release.

• Inspection readiness experience in the United States and ex-US markets.

• Technical knowledge of small molecule process chemistry, process controls, impurity management, analytical testing, specifications, and validation.

• Knowledge of applicable US and global GMP regulations and industry practices.

• Experience with deviations, investigations, OOS/OOT, CAPAs, change controls, and risk assessments.

• Ability to assess complex manufacturing and analytical issues and make risk-based Quality decisions.

• Strong leadership, collaboration, and stakeholder management skills.

• Ability to manage multiple priorities, external partners, and aggressive timelines.

• Sound judgment, attention to detail, self-motivation, and commitment to product quality.

• Proficiency with Microsoft Office and electronic quality/document management systems.

• Experience reviewing CMC content for IND/IMPD/NDA submissions and post-approval changes.

Preferred Skills:

• Commercial DS/DPI disposition and post-approval change experience is preferred.

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