QA Manager Documentation Review - Onsite Mississauga
Core
Lead QA teams responsible for GMP production documentation review, laboratory data review, and batch disposition to ensure compliance and data integrity.
Role type
Senior Manager, Quality Assurance (Production Documentation & Lab Data)
Builds
Compliant pharmaceutical production batches and validated laboratory data
Domain
Pharmaceutical/Biopharmaceutical Manufacturing (GMP)
Required skills
GMP regulations, ALCOA+ data integrity, batch record review, laboratory data review, team leadership, regulatory inspection support, CAPA, change control, quality risk management, electronic records (21 CFR Part 11)
Preferred skills
Six Sigma certification, LIMS/Empower/SAP/MES experience, laboratory investigation processes
Technologies
TrackWise, LIMS, Empower, SAP, MES
Responsibilities
Lead and develop supervisors and individual contributors for documentation and lab review teams; oversee timely review and approval of batch records and lab data; monitor performance metrics and review queues; support deviations, investigations, and regulatory audits; drive continuous improvement in review workflows and data integrity.
Seniority
Senior, hands-on IC with people management
