Senior Quality Assurance Manager for PET Radiopharmaceutical Laboratory
2 weeks ago
Key Responsibilities:
The Quality Assurance Manager will be responsible for developing and implementing a Quality Assurance (QA) program for the PET Radiopharmaceutical Laboratory to ensure compliance with Health Canada regulations and Good Manufacturing Practices (GMP).
This role will lead and support the Molecular Imaging & Therapy Quality Program for BC Cancer – IAMI, ensuring that all applicable quality-directed policies and procedures are implemented and followed.
Key Accountabilities:
- Develop and implement plans to ensure the PET Radiopharmaceutical Laboratory meets or exceeds Health Canada regulatory requirements.
- Conduct ongoing audits of GMP compliance, provide training and guidance to staff, and oversee the PET radiopharmaceutical manufacturing and distribution program.
- Coordinate and monitor the quality assurance program, ensure that complaints, errors, accidents, and deficiencies are documented, controlled, and investigated as appropriate, and report results to management.
- Maintain quality system-related records and reports, including audit reports involving critical incidents and adverse events, and liaise with regulatory bodies such as Health Canada.
Requirements:
The ideal candidate will have a Bachelor's degree in a related science/technology field and five (5) years of recent, related leadership experience in the pharmaceutical industry, including experience and formal documented training in good manufacturing practice and quality management, and experience training and leading teams in a GMP-compliant pharmaceutical production facility.
Preferred Qualifications:
- Strong knowledge of Health Canada guidelines as they pertain to Schedule C Drugs and PERs.
- Knowledge of Health Canada and/or other regulatory agency inspections and internal and/or vendor audits.
- Aptitude to facilitate regulatory and/or client audits.
- Competency with computer applications such as Microsoft Office and information and document management systems.
- Organizational and time management skills.
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About PHSA:
PHSA is a provincial health services authority that plans, manages, and evaluates specialized health services across British Columbia. Our values reflect our commitment to excellence and include respect for people, compassion, innovation, partnerships, and serving with purpose.
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