Manager, Quality Assurance
Location:West Coast US+Canada (Hyrbid)
The Manager, Quality Assurance, is responsible for ensuring investigational medicinal products (IMPs) meet current Good Manufacturing Practices (cGMP). 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 guidelines
• Spearhead continuous quality improvement activities
• Oversee the implementation, manage the content, coordination, and execution of our client's electronic Quality Management System (eQMS).
• Define and manage the delivery of training programs for employees via the eQMS
• Coordinate external audits, internal audits and gap analyses
• Manage 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 records
• Lead 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 issues
• Drive 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 procedures
• Lead inspection readiness preparation and training
• Review and approve new procedures, specifications, analytical methods and other quality documentation as required
• Collaborate cross-functionally to ensure the implementation of required procedures, best practices and adherence to regulatory requirements and GCP guidelines
• Negotiate and maintain Quality Agreements with GXP service providers
• Build and maintain strong working relationships with members of the CMC, Regulatory Clinical Operations and Supply Chain teams
Education, 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 transfer validation/ manufacturing/testing/ CMC or equivalent combination of education and experience
• Knowledge of GCP and experience with clinical operations would be an asset
Demonstrated experience with eQMS Tools, Gantt Charts, Excel Spreadsheets and Project Planning tools, Smartsheet
• Experience in planning, organizing and conducting audits.
• Experience in preparing for inspections ideal
• 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.
Salary Range: $95,000 to $130,000, depending on education and relevant experience
While only short-listed candidates will be notified, we thank each applicant for their submission
