Associate Director, Quality Assurance- GMP Operations
Core
Senior Quality leadership providing direct oversight of GMP Manufacturing, QC, and Supply Chain operations to ensure compliance and patient safety.
Role type
Associate Director, Quality Assurance (GMP Operations)
Builds
Compliant pharmaceutical/biotech products for global distribution
Domain
Pharmaceutical/Biotechnology Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, Quality Risk Management, regulatory inspection readiness, batch disposition, CAPA management, change control, people management, cross-functional collaboration
Preferred skills
Health Canada/FDA inspection experience, materials management systems knowledge
Technologies
GMP documentation systems, batch record systems
Responsibilities
Provide QA oversight of GMP Manufacturing, QC, and Supply Chain; Apply Quality Risk Management principles; Partner with teams to mitigate quality risks; Review and approve manufacturing records, deviations, investigations, and CAPA; Participate in internal GMP audits and regulatory inspections; Approve GMP documentation and procedures; Lead and mentor Quality personnel.
Seniority
Senior, hands-on IC with leadership responsibilities
