Associate Director, API Quality Assurance (GMP)

Role: Lead GMP API Quality Assurance to ensure compliant, risk-based oversight of active pharmaceutical ingredient manufacturing at external CMOs/CDMOs. Responsibilities include developing API QA strategy, managing quality of API and intermediate production, review of batch documentation, deviation and change control processes, and leading inspection readiness and audits. The role involves performance management of API partners, oversight across the API lifecycle, and collaboration with MSAT, CMC, Regulatory, and Supply Chain teams for tech transfer and lifecycle management. Requirements: BS or MSc in Chemistry, Chemical Engineering, Pharmacy, or related field; 10-12 years GMP experience with a focus on API quality; proven leadership in API batch disposition, deviation, and change control governance; strong knowledge of ICH Q7, FDA, EMA expectations; experience managing external API manufacturers and supporting health authority inspections. Preferred: advanced degrees, experience with small molecule APIs, oligonucleotide manufacturing, Veeva Vault Quality, and external manufacturing networks. HighValue: API quality governance, risk-based oversight, external partner management, inspection readiness, and compliance with global GMP standards.