Manager, Quality Assurance

Manager, Quality AssuranceLocation: 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
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