Associate Director, Quality Assurance
Core
Lead end-to-end quality and compliance for a critical manufacturing site, ensuring safety, efficacy, and regulatory excellence while enabling reliable supply to the market.
Role type
Senior IC Site Quality Head (Manufacturing)
Builds
Animal health products (medicines and vaccines) for human and animal use
Domain
Bioscience / Animal Health Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Quality Management Systems (QMS), Quality Control (QC), manufacturing processes, regulatory inspections, recall management, EHS management, strategic planning, change management, team leadership, supplier quality management
Preferred skills
None explicitly stated beyond required skills
Technologies
Computer System Validation (CSV), Performance Qualification (PQ), GMP Laboratory systems
Responsibilities
Lead quality operations and ensure product quality/compliance status; manage site Quality budget; partner with global supply chain and commercial functions; serve as primary contact for regulatory agencies; direct recall and stop sales activities; host regulatory inspections; lead and coach quality managers and specialists; develop and maintain GMP systems and procedures; ensure EHS compliance and hazard control; oversee major site capital investments impacting product quality
Seniority
Senior, hands-on IC with leadership responsibilities
