Sanofi Group Deputy Director R&D SQO in Toronto, Ontario

Position Summary

The Deputy Director SP R&D Site Quality Operations (Toronto) will provide management, quality oversight and leadership for activities related to research and development for sterile manufacturing of vaccines for use in clinical trial, and will have a team of R&D quality professionals reporting to the role.

Key Responsibilities and Accountabilities

  • Ensures GMP R&D QA support for all development phases of new vaccines and technology projects, providing technical, quality and compliance expertise, risk-based, quality-decision making, and timely release of clinical trial material and components

  • Accountable for ensuring company policies , site procedures and standards are consistently met and implemented for R&D products, and that assigned areas meet current FDA and International Regulatory requirements

  • Provides leadership and direction to Manufacturing (including testing, release) and Support functions to ensure a constant state of inspection readiness, and ensures that audit observations are addressed quickly and completely

  • Responsible for maintenance of Quality Systems and continuous improvement initiatives (e.g., Document management, Master records, Deviation, CAPA and Change Management)

  • Provides leadership, direction and recommendations for team to enable timely closure and completion of Deviations, Change Controls and CAPAs, while making sure the right level of quality is maintained

  • Responsible to build and maintain an effective Quality team, able to partner and maintain strong alignment with local functional stakeholders and across global R&D Quality sites, and successfully deliver on project and continuous improvement commitments

  • Accountable for leadership and management of a team of quality professionals, setting clear expectations and objectives, providing regular feedback and development support, and evaluating performance against well-defined standards

Education/Experience/Skills/Competencies

  • (Minimum) Bachelor of Science Degree in a relevant discipline (eg. Biology, Microbiology, Biochemistry)

  • (Preferred) Advanced Science Degree in a relevant discipline

  • 8-12 years related experience in the Pharmaceutical Industry

  • Strong technical background, expertise in vaccines or biologics with demonstrated knowledge of quality practices Familiar with quality oversight of third party suppliers and sub-contractors, including quality agreements , audits and QTP management

  • Strong skills in decision making, problem solving and critical thinking

  • Excellent report writing and communication skills based on global interaction and ability to build solutions and partnerships

  • Excellent knowledge of the GMPs for US, Canada and Europe

#LI-SP

#GD-SP

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life