Summary:
- The Manager QTP, R&D Quality Vaccines will support the management of: Quality Systems, Quality Third Parties, Self-inspections, and support quality projects/initiatives that ensure quality and compliance of new vaccines development in accordance with cGMP standards, and regulatory and internal requirements.
Quality Systems:
- Responsible for maintenance of Quality Systems and compliance (revision of procedures, accurate and up-to-date records in Quality Systems).
- Supports alignment of local procedures with global standards.
- Responsible for maintaining its own training compliance.
- Support evolution of the Quality Systems model for QualiPSO and MOSAIC projects, specifically for R&D Toronto.
- Update procedures (SOP’s/training curricula) to capture updated practices and accountabilities according to QualiPSO implementation of each workstream, as per the QualiPSO project timelines for each process.
- Support the preparation of various reports (deviation trends, periodic access reviews) throughout the term.
Quality Third Party (QTP) and Self-Inspections/Audits:
- Responsible for the management and evolution of the third-party processes, in alignment with Sanofi Global requirements and regulations.
- Accountable to ensure appropriate quality oversight and performance evaluation (including SCNs, QSTPs, supplier deviations) of third-party suppliers, sub-contractors and service providers used by R&D Toronto.
- Ensures quality agreements with third parties are developed and managed during their lifecycle.
- If the incumbent is a qualified auditor, may perform external audits (as required) and self-inspections.
- Responsible for change management activities related to the QTP program and other Quality Systems (as required).
- Responsible for identifying opportunity for improvements to quality processes through the review and evaluation of vendor performance and by recommending appropriate resolutions.
Other:
- Keeps updated and shares within R&D new rules and industry regulations, and to define and align internal quality systems with best practices.
- Works within the policies, procedures and regulations as required by the Company and under the Occupational Health and Safety Act.
Required Qualifications:
- (Minimum) Bachelor of Science Degree in a relevant discipline (e.g. Biology, Microbiology, Biochemistry, Immunology, Chemistry, Biotechnology)
- 6-10 years related quality experience in the pharmaceutical industry.
- Strong technical background, expertise in vaccines or biologics with demonstrated knowledge of quality practices.
- Familiarity with quality third party management, audits, and Vaccine manufacturing processes and testing, are fundamental in performing the job.
- Strong skills in decision making, problem solving and critical thinking.
- Strong written and communication skills are critical to ensure team members are guided through cGMP (Quality System) requirements.
- Excellent knowledge of the GMPs for US, Canada and Europe.
- Ability to work in group setting and independently; ability to adjust to changing priorities.
- Strong customer and results orientation.
- The incumbent will be required to actively balance the quantity of their work with an acceptance level of quality while ensuring compliance.
- The position requires strong organization and a good level of autonomy. Decision making is key and will require investigation or interpretation of information received from multiple sources.
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