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.
#LI-Hybrid #LI-JC1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Base Pay Salary Range
$186,000-$233,000 USD
