Associate Director Quality Operations

Role: Associate Director, Quality Operations, responsible for overseeing external manufacturing and supply chain quality for biopharma products supporting EU and international markets. Objectives include ensuring GMP compliance, batch release, deviation management, supplier qualification, and regulatory support for commercialization. Responsibilities encompass batch record review, lot disposition, supplier and vendor oversight, quality agreement management, performance tracking via KPIs, distribution quality, serialization, and supporting regulatory inspections. Qualifications: Bachelor’s in life sciences, engineering, or related field; 10+ years in QA within biotech/pharma; extensive experience managing CMOs, CDMOs, and external supply networks; strong knowledge of EU/UK GMP and GDP, US regulations, ICH guidelines, and batch certification procedures. Preferred skills include familiarity with electronic QMS (e.g., Veeva, TrackWise), combination products, cold-chain qualification, temperature excursion assessment, and serialization/FMD. High-value specifics: focus on external manufacturing, international supply chain, and regulatory compliance; supporting batch release and GMP readiness for global markets. Collaboration is primarily with external manufacturing partners, QP, and internal teams. Work is remote, with potential international travel up to 20% for site visits and audits.