Associate Director, API Quality Assurance (GMP)
J
JobgetherPharmaceutical / Biotechnology
Based in United StatesFull-TimeManager
Salary$169,000 - $198,000
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Job Details
- Experience
- 10-12 years
- Required Skills
- Quality Assurance
Requirements
- Bachelor’s or Master’s degree in a scientific discipline such as Chemistry, Chemical Engineering, Pharmacy, or a related field.
- 10-12 years of GMP pharmaceutical or biotechnology experience with significant focus on API quality and external manufacturing oversight.
- Proven experience managing API batch disposition, deviation investigations, CAPA processes, and change control governance.
- Strong knowledge of ICH Q7, ICH Q8-Q11, FDA, EMA, and global API regulatory expectations.
- Demonstrated ability to manage external API manufacturers and support regulatory inspections.
- Experience with small molecule API and/or oligonucleotide manufacturing is preferred.
- Experience supporting technology transfers, validation programs, and post-approval changes at API manufacturing sites.
- Familiarity with Veeva Vault Quality or similar electronic quality management systems (eQMS).
- Strong expertise in quality governance, risk-based decision-making, and partner performance management.
- Excellent communication, influencing, and leadership skills with the ability to present complex quality topics to senior stakeholders.
Responsibilities
- Lead GMP API Quality Assurance strategy, governance processes, and quality standards across external API manufacturing partners.
- Provide oversight of API and intermediate manufacturing activities to ensure compliance with global GMP requirements and ICH Q7 expectations.
- Establish and maintain standards for API batch documentation review, quality decisions, and traceability of quality rationale.
- Drive review and management of deviations, investigations, root cause analyses, CAPAs, and effectiveness checks.
- Oversee change control processes related to API manufacturing processes, specifications, analytical methods, and partner-led changes.
- Manage quality agreements, performance reviews, KPIs, scorecards, and governance meetings with external manufacturing partners.
- Collaborate with technical operations, supply chain, regulatory, and manufacturing teams to support technology transfers, validation activities, and lifecycle management.
- Maintain inspection readiness through robust documentation practices, audit preparation, evidence packages, and health authority response support.
- Analyze quality trends and provide strategic insights to prevent recurrence and improve manufacturing performance.
- Mentor QA professionals and contribute quality expertise across cross-functional decision-making forums.
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