Manager, Quality Assurance
$95,000–$130,000 year
On-siteVancouver, British Columbia, Canada or Vancouver, Washington, United States
Job Summary
Ensure investigational medicinal products meet current Good Manufacturing Practices by executing hands-on batch reviews, managing vendor oversight, and leading extensive investigations to resolve quality issues. Establish and maintain procedures aligned with ICH GXP guidelines while overseeing the electronic Quality Management System, including training delivery, audit coordination, and gap analysis. Manage contract manufacturers and testing labs to ensure deliverables meet specifications, review CMC documents for regulatory submission, and develop standard operating procedures. Act as the single point of QA contact for vendors and collaborators regarding contracts, validation, and change management. Collaborate cross-functionally with CMC, regulatory, and clinical teams to drive compliance and inspection readiness.
Required Qualifications
- B.S. in a science related discipline (preferably in chemistry, biochemistry, or chemical engineering)
- 8+ years related experience in the biotechnology or pharma industry with a sound knowledge and focus on GMP operations, process development/technology transfer validation/ manufacturing/testing/ CMC or equivalent combination of education and experience
- Demonstrated experience with eQMS Tools, Gantt Charts, Excel Spreadsheets and Project Planning tools, Smartsheet
- Experience in planning, organizing and conducting audits
- Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
- Critical thinker, outgoing and enthusiastic and well-organized
- Excellent written, spoken, listening and presentation skills and a demonstrated ability to influence within the wider project team at the level of functional leadership
- Self-motivated; able to work independently and within a team
- Excellent time management and multi-tasking skills
- Maintains a composed, collaborative and independent manner when dealing with issues, challenges, conflicts and opportunities
Desired Qualifications
- Knowledge of GCP and experience with clinical operations would be an asset
- Experience in preparing for inspections ideal
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