Assoc Director, Quality Assurance
Core
Provide Quality Assurance oversight of GMP Manufacturing and QC testing operations, ensuring compliance with cGMP and regulatory standards for biologics.
Role type
Senior IC Quality Assurance Director (GMP/Biologics)
Builds
Drug products and biologics therapies
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
GMP operations oversight, Quality Risk Management, CAPA management, regulatory inspection readiness, cross-functional leadership, digital manufacturing workflow development
Preferred skills
Health Canada/FDA inspection experience, Six Sigma/DMAIC methodology, HACCP/FMEA tools
Technologies
Computer Systems Validation (CSV), ICH Guidelines, digital manufacturing data solutions
Responsibilities
Oversee GMP manufacturing and QC testing from master cell bank to drug product; Review and approve laboratory investigations and CAPA; Partner with cross-functional teams to mitigate quality risks; Lead internal GMP audits and serve as contact during regulatory inspections; Provide leadership and mentoring for Quality personnel; Oversee implementation of digital manufacturing solutions.
Seniority
Senior, hands-on IC with people management