Quality Assurance Senior Leader
Our client, a major actor in the fight against COVID-19, is looking for a Quality Assurance Senior Leader to join their Montreal team. The person will be responsible for ensuring the development and management, monitoring, and reporting of the quality system within the biologics manufacturing site in accordance with standard practices applicable to the pharmaceutical industry (GMP, GCP, GVP and GLP).
- Establishes and maintains a quality assurance system.
- Defines the needs in quality management by following the industry standards and by adapting to the needs of the laboratory, its partners, and clients.
- Set up and manage supplier quality agreements.
- Ensure, in collaboration with managers and project leaders, the quality assurance system is compliant according to the project quality assurance needs.
- Manages controlled documentation.
- Revise and approve internal procedures and those of suppliers as needed in order to ensure they are compliant with the requirements of the GMP and internal standards.
- Supervise staff and ensure their professional development.
- Determine the objectives, priorities, and performance measures and establish training and development plans.
- Bachelor of Science in Life Sciences (i.e. Microbiology, Biochemistry, Biotechnologies or equivalent).
- Master’s degree in a related discipline, an asset.
- Experience in pharmaceutical bioprocedures (biologics and vaccines).
- Experience in a management position.
- Significant experience in quality assurance management, documentation, and regulation in the area of biopharmaceutical.
- Advanced knowledge of GMP quality assurance practises as applied to biopharmaceutical products.
- Bilingualism in French and English, both oral and written.
- Excellent adaptability and flexibility.
- Strong leadership and team spirit
- Ability to work in a fast-paced environment.
- Effective communication skills, both verbal and written.
Please submit your resume directly to Céline Chabée at email@example.com, indicating “Quality Assurance Senior Leader” in the title of the email.
Only selected candidates will be contacted.