Senior / Principal Associate QA API External Manufacturing

Role: Senior/Principal QA Associate for external manufacturing of APIs, ensuring compliance with cGMP standards across manufacturing sites. Responsibilities: review and approve manufacturing documentation, lead audits, oversee quality events, collaborate on technology transfers, monitor quality metrics, and support regulatory inspections. Requirements: Bachelor's in Chemistry, Pharmacy, or Chemical Engineering; 5+ years (Senior Associate) or 8+ years (Principal) QA experience in pharma/biopharma, with API manufacturing expertise; deep knowledge of cGMP (21 CFR, ICH Q7); audit and quality event management skills; strong communication and problem-solving abilities. HighValue: API manufacturing, external supply chain, cGMP compliance, regulatory audit support, international quality standards. WorkSetup: full-time, with domestic/international travel up to 25%.