Associate Director, API Quality Assurance (GMP)

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for an Associate Director, API Quality Assurance (GMP) based in United States.

This leadership role oversees GMP quality assurance activities for active pharmaceutical ingredient (API) and intermediate manufacturing across external partners. The position plays a critical role in ensuring regulatory compliance, product quality, and reliable supply throughout the API lifecycle. Working closely with manufacturing partners and cross-functional teams, the role drives quality governance, continuous improvement, and inspection readiness. The successful candidate will provide strategic oversight across external manufacturing networks while strengthening quality systems and operational excellence. This opportunity is ideal for an experienced pharmaceutical quality professional passionate about innovation, collaboration, and advancing life-changing therapies. The role offers significant visibility and impact in a growing environment focused on scientific excellence and patient outcomes.

Accountabilities:: The Associate Director, API Quality Assurance is responsible for developing and executing quality strategies that ensure compliant API manufacturing operations across external partners. This role provides expert guidance, manages quality risks, and drives alignment between internal teams and external manufacturers.

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.

Requirements:

The ideal candidate brings extensive pharmaceutical or biotechnology quality experience, with deep expertise in API manufacturing oversight, regulatory compliance, and external partner management. The role requires 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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1