Director, Quality Assurance (GMP Operations)
Core
Senior Quality leadership and direct oversight of Manufacturing and Quality Control (QC) operations for a new Single Use DS Biologics Manufacturing facility and QC Laboratory.
Role type
Director, Quality Assurance (GMP Operations)
Builds
State-of-the-art biologics manufacturing facility and QC laboratory
Domain
Biologics manufacturing, GMP, Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (GMP Manufacturing & QC)
Required skills
GMP/GLPs, QA principles, Computer Systems Validation, ICH Guidelines, Six Sigma/DMAIC, Risk Management (HACCP/FMEA), Biologics manufacturing, CAPA, Change management, People management
Preferred skills
Regulatory inspection experience (Health Canada, FDA)
Technologies
Single Use DS Biologics Manufacturing systems, Digital manufacturing data solutions
Responsibilities
Provide QA oversight of GMP Manufacturing and QC testing operations from master cell bank to drug product; Review and approve laboratory investigations (OOS/OOT/deviations) and CAPA; Apply Quality Risk Management principles to oversee risk assessments; Participate in internal GMP audits and serve as key contact during regulatory inspections; Approve GMP documentation including procedures, batch records, and specifications; Provide leadership, development, and mentoring for Quality personnel.
Seniority
Director, strategic oversight & people leadership