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Quality Assurance Manager, PET Radiopharmacy
BC Cancer
Vancouver, BC
The Quality Assurance Manager 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.
What you’ll do
- Develop and implements 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 monitors 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.
What you bring
Qualifications:
- 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.
You have:
- 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.).
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What we bring
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.
Job Type: Regular, Full-Time Wage: $88,990-$127,923 per year Location: 750 West Broadway, Vancouver, BC V5Z 1K1
Application will be accepted until position is filled.
Hours of Work: Monday – Friday; 0800-1600 Requisition Number: 167607E
What we do
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: jobs.phsa.ca/programs-and-services
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.
ATTN: PHSA Employees:
To be considered as a PHSA employee (internal applicant) for this position, you must apply online via your internal profile at http://internaljobs.phsa.ca
Please note the internal job posting will no longer be accessible after the expiry date of June 26, 2024. If the internal job posting has expired, please contact the Internal Jobs Help Desk and advise that you would like to be considered as a late internal applicant for this position. Please do not apply for the external job posting.
If you have not registered your internal profile, a password is required to log in for the first time. To obtain your password, please contact the Internal Jobs Help Desk at 604-875-7264 or 1-855-875-7264. Please note regular business hours are Monday – Friday (excluding stats), 8:30am to 4:30pm. For inquiries outside of regular business hours, please email the Internal Jobs Help Desk at internaljobshelpu@phsa.ca and a Help Desk Representative will contact you the next business day.
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Privacy Policy
Provincial Health Services Authority (PHSA) respects your right to privacy and takes seriously its responsibilities regarding the collection, use and disclosure of your personal information. Personal information is collected under the authority of the Freedom of Information and Protection of Privacy Act of BC, section 26 (c). The personal information that we collect from you or about you when applying for a job with PHSA will be used to assess your qualifications and suitability as a potential employee of PHSA, as well as for the purposes of recruitment and onboarding. We may also collect and use additional personal information provided by you or your references in the course of the evaluation and hiring process that will become part of your employment file if you are a successful candidate.
Your contact information, education and experience, desired job location and pay information, eligibility and availability, core skills, job functions, getting to know you responses, resumes, cover letters, references, pre-screening questionnaire responses and job application history is recorded in PHSA’s third-party applicant tracking system (“Brainhunter”)in Canada indefinitely and will be shared with our staff on a “need to know” basis. If you require access to your data, PHSA can provide a printout of your data and job application history. We do not sell or rent the information you provide to us to third parties. However, we do contract with a service provider to assist us in maintaining and managing our databases and to communicate with job applicants. We do not authorize this third party to make any other use of your information.
The service provider (“Brainhunter”) allows the option for you to delete your account after signing into the system. Before deletion you are advised with a warning. Your record is permanently purged / deleted from the respective site and the record will not be available in any searches. The job will have only the respective application information that you made previously.
To view the third party vendor privacy policy please refer https://www.brainhunter.com/EN/Privacypolicy.html.
Under certain circumstances, some personal information may be disclosed pursuant to the Freedom of Information and Protection of Privacy Act of B.C. For example, where we believe in good faith that the law requires disclosure of such information in response to legal process and law enforcement rights. Security measures have been integrated into the design, implementation and day-to-day operating practices as part of PHSA's continuing commitment to the protection of personal information it holds. View our PHSA Privacy Policy.
If you have any questions about the management of your personal information during the recruitment process, please contact the Manager, Talent Acquisition at 604-875-7251, toll free 1-866-744-7363 or #260 – 1770 West 7th Avenue, Vancouver BC, V6J 4Y6. You may also contact External Recruitment at careers@phsa.ca.
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