Associate Director, API Quality Assurance (GMP)

Accountabilities

• Develop and execute quality strategies for compliant API manufacturing operations across external partners.
• Provide expert guidance, manage quality risks, and drive alignment between internal teams and external manufacturers.
• Lead GMP API Quality Assurance strategy, governance processes, and quality standards across external API manufacturing partners.
• 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.

Requirements

• Extensive pharmaceutical or biotechnology quality experience, with deep expertise in API manufacturing oversight, regulatory compliance, and external partner management.
• Strong leadership skills, technical knowledge, and the ability to communicate effectively across global teams.
• 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.

Benefits

• Competitive annual salary range of $169,000 - $198,000.
• Equity opportunities allowing employees to share in organizational success.
• Performance-based compensation opportunities.
• Comprehensive medical, dental, vision, and life/disability insurance plans.
• Flexible paid time off programs.
• 401(k) retirement plan options with employer matching.
• Mental health support through an Employee Assistance Program.
• Additional voluntary benefits, including supplemental life insurance and legal services.
• Opportunities to contribute to innovative healthcare solutions in a collaborative biotechnology environment.
• Professional growth opportunities within a high-impact scientific organization.