3006 QA Manager: Biomanufacturing

Title of the Job: 3006 QA Manager: Biomanufacturing

Location: Toronto, ON

Job Description: Join a rapidly expanding, successful Canadian biologics and medical device developer and manufacturer. Our client supplies the international clinical diagnostic marketplace with biological drugs and diagnostic testing products, promoting and enhancing human health.As a QA Quality Assurance Manager, you will responsible for a broad variety of QA processes – e.g. risk management, ISO, eQMS, design control, process validation, metrics, audits. Position manages 10 people and reports to QA Director.ROLE AND RESPONSIBILITIES:

• Meet requirements for several sites: including all aspects of QA as well as R&D GMP compliance.
• Supervise approximately 10 people, supporting and holding them accountable at the same time.
• Scheduling and monitoring all functions.
• Promotable to more senior position.
• Strong contributor, adding value to the company.
• Non-conformance investigations, process validation, risk management, CAPA, continuous improvement.
• Manage customer quality agreements and other quality requirements.
• Compliance SME, audit representative, contribute to QMR Quality Management Reviews.
• Implement MasterControl QMS software, ensuring it meets current ISO 13485 and 9001, EU IVDR, Health Canada standards.
• Vendor management.

REQUIREMENTS:

• BS / MS Life Sciences. CQA nice to have.
• Min 8 to 10 years in QA within life sciences, min 5 managing 5 to 10 people.
• Biologics / medical device development and manufacture experience.
• Used to doing scheduling of team activities and monitoring performance and completion.
• Background implementing MasterControl or similar eQMS software.
• Knowledge of GMP, ISO, FDA, Health Canada, EU requirements and standards.
• Project management and risk management skills.
• CAPA, SOPs, non-conformance, remediation, audit, validation background.
• Excellent people, computer, and project management skills.

Company Name: Hess Associates

Salary:

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