Manager, Quality AssuranceLocation: West Coast US+Canada (Hyrbid)The Manager, Quality Assurance, is responsible for ensuring investigational medicinal products (IMPs) meet current Valuable Manufacturing Practices (c GMP). This role serves as a quality partner to internal teams, executing hands-on batch reviews, investigations, vendor management and compliance oversight while seamlessly bridging the gap between technical, clinical, and regulatory operations.Key responsibilities and duties:Ensure procedures and systems are established and maintained to ensure the Company’s compliance with ICH GXP guidelines; current national and international legislation; and relevant regulations, standards and guidelinesSpearhead continuous quality improvement activitiesOversee the implementation, manage the content, coordination, and execution of our client’s electronic Quality Management System (e QMS).Define and manage the delivery of training programs for employees via the e QMSCoordinate external audits, internal audits and gap analysesManage the QA oversight of contract manufacturers and testing labs (internal/external) to ensure products/deliverables meet all required quality standards and specifications.Perform rapid and agile record review and disposition activities for clinical trial material including manufacturing,



testing and labelling/packaging batch recordsLead extensive investigations with vendors and interdepartmental teams to determine product quality impact and resolve potential product quality issues.Act as the single point of QA contact with vendors, contract facilities and joint development collaborators for contracts, validation activities, change management and other QA issuesDrive the implementation of other quality systems, including departmental and corporate procedures, to ensure compliance with GXPs.Review CMC documents submitted to regulatory agencies.Develop work instructions and/or standard operating proceduresLead inspection readiness preparation and trainingReview and approve new procedures, specifications, analytical methods and other quality documentation as requiredCollaborate cross-functionally to ensure the implementation of required procedures, best practices and adherence to regulatory requirements and GCP guidelinesNegotiate and maintain Quality Agreements with GXP service providersBuild and maintain strong working relationships with members of the CMC, Regulatory Clinical Operations and Supply Chain teamsEducation, qualifications and work experience: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

📌 Manager, Quality Assurance (Vancouver)
🏢 NWRPros
📍 Vancouver