Quality Assurance Manager PET Radiopharmaceutical Laboratory
1 month ago
Quality Assurance Manager PET Radiopharmaceutical Laboratory
BC Cancer
Vancouver, BC
The Quality Assurance Manager PET Radiopharmaceutical Laboratory is responsible for developing and maintaining a Quality Assurance (QA) program for the Positron Emission Tomography (PET) Radiopharmaceutical Laboratory to ensure the laboratory exceeds all Health Canada regulatory requirements necessary to be licensed as a GMP-compliant facility in compliance with Good Manufacturing Practices (GMP). This role is responsible for PET directed quality assurance activities and ensures that all applicable quality directed policies and procedures are appropriately implemented and followed.
This role will be leading and supporting the Molecular Imaging & Therapy Quality Program for BC Cancer – IAMI. This role will require on-site presence at 4004 Wesbrook Mall, Vancouver BC V6T 2A3, with remote work as appropriate.
Key Responsibilities
- Develop and implement plans to ensure that PET Radiopharmaceutical Laboratory meets or exceeds all Health Canada regulatory requirements necessary to be licensed as a GMP-compliant facility and is fully prepared for Health Canada compliance audits or other accreditation bodies.
- Conduct ongoing audits of GMP compliance both in-house and externally for suppliers, contract laboratories, and other service providers, provides training and guidance to staff, and oversees the PET radiopharmaceutical manufacturing and distribution program.
- Coordinate and monitor the quality assurance program, monitors the implementation of quality assurance policies and procedures, ensures that complaints, errors, accidents and deficiencies are documented, controlled, and investigated as appropriate and corrective actions implemented when required, and reports results to management. Identifies alternatives and strategies for the delivery of quality practices.
- Maintain quality system related records and reports, including the writing of audit reports involving critical incidents and adverse events and liaises with appropriate regulatory bodies such as Health Canada.
Requirements
- A level of education, training, and experience equivalent to 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.
- 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.
- Oral and written communication skills.
- Awareness of and commitment to learning and understanding the Truth & Reconciliation Commission's 94 Calls to Action (2015), In Plain Sight Report (2020), BC's Declaration on the Rights of Indigenous Peoples Act (2019), and Reclaiming Power and Place Missing and Murdered Indigenous Women & Girls calls for justice, and how they intersect across the health care system.
- Support team members on their learning journey, ensuring education strategy for team/department to implement Indigenous Cultural Safety at a practical level.
- Work collaboratively with appropriate Indigenous teams/departments to ensure ICS lens applied holistically.
- Have commitment to upholding the shared responsibility of creating lasting and meaningful reconciliation in Canada as per TRC (2015) and BC's Declaration on the Rights of Indigenous Peoples Act (2019).
- Knowledge of social, economic, political and historical realities impacting indigenous communities and familiarity with Indigenous Cultural Safety and anti-racism and accompanying reports (BC DRIPA, TRC, etc.).
About PHSA
Every PHSA employee enables the best possible patient care for our patients and their families. Whether you are providing direct care, conducting research, or making it possible for others to do their work, you impact the lives of British Columbians today and in the future. That's why we're focused on your care too – offering health, wellness, development programs to support you – at work and at home.
- Join one of BC's largest employers with province-wide programs, services and operations – offering vast opportunities for growth, development, and recognition programs that honour the commitment and contribution of all employees.
- Access to professional development opportunities through our in-house training programs, including +2,000 courses, such as our San'yas Indigenous Cultural Safety Training course, or Core Linx for Leadership roles.
- Enjoy a comprehensive benefits package, including municipal pension plan, and psychological health & safety programs and holistic wellness resources.
- Annual statutory holidays (13) with generous vacation entitlement and accruement.
- PHSA is a remote work friendly employer, welcoming flexible work options to support our people (eligibility may vary, depending on position).
- Access to WorkPerks, a premium discount program offering a wide range of local and national discounts on electronics, entertainment, dining, travel, wellness, apparel, and more.
Application Information
Application will be accepted until position is filled.
As per the current Public Health Order, full vaccination against COVID-19 is a condition of employment with PHSA as of October 26, 2021.
About BC Cancer
BC Cancer provides comprehensive cancer control for the people of British Columbia.
BC Cancer program is part of the Provincial Health Services Authority (PHSA).
PHSA plans, manages and evaluates specialized health services with the BC health authorities to provide equitable and cost-effective health care for people throughout the province. Our values reflect our commitment to excellence and include: Respect people – Be compassionate – Dare to innovate – Cultivate partnerships – Serve with purpose.
Learn more about PHSA and our programs:
PHSA and BC Cancer are committed to employment equity, encouraging all qualified individuals to apply. We recognize that our ability to provide the best care for our diverse patient populations relies on a rich diversity of skills, knowledge, background and experience, and value a safe, inclusive and welcoming environment.
Reconciliation is an ongoing process and a shared responsibility for all of us. The BC Governments' unanimous passage of the Declaration on the Rights of Indigenous Peoples Act was a significant step forward in this journey—one that all health authorities are expected to support as we work in cooperation with Indigenous Peoples to establish a clear and sustainable path to lasting reconciliation. True reconciliation will take time and ongoing commitment to work with Indigenous Peoples as they move toward self-determination. Guiding these efforts Crown agencies must remain focused on creating opportunities that implement the Truth and Reconciliation Commission Mandate.
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