Deputy Director GMP Compliance
Toronto, Canada
1d ago

Reference No. R2553084

Position Title : Deputy Director GMP Compliance

Summary of Purpose :

This position is responsible for leading the CAPA management system, process for implementation of Sanofi Policies & Standards and inspection lifecycle activities for Regulatory, Global / Corporate and Third Party / Customer inspections of Sanofi Pasteur Limited.

The objective of this function is to ensure :

  • 1) compliance, adherence to best practice and monitoring of the overall health of the CAPA management system;
  • 2) management of the overall lifecycle of inspections, including readiness, scheduling, logistics and responses to findings;
  • 3) ensure that the Toronto site is in compliance with current Good Manufacturing Practices, corporate and regulatory policies and standards pertaining to the supply, manufacture, control and distribution of Sanofi Pasteur Limited’s products.

    Key Accountabilities :

  • Ensure strategy is in place and executed for the site's Regulatory, Global / Corporate and Third Party / Customer inspections lifecycle including : readiness planning / execution, scheduling, logistics, inspection management, finding response and corrective action implementation.
  • This includes the preparation, management of the logistics, response management and tracking

  • Lead the CAPA management system ensuring overall compliance and its health. Work with areas to ensure appropriate CAPAs are built and collectively tracked to ensure KPIs are met
  • Manage the process for implementation of Sanofi Directives, Standards and Guidance documents. Assign SEs for each global document, ensure gap assessments are performed and CAPAs are created in a timely manner
  • Provide leadership and establish departmental objectives to align with site objectives for safety, quality, productivity, cost, and continuous improvement.
  • Build and maintain a high performing team, providing effective alignment and communication with functional groups at the site and at other manufacturing sites, to successfully deliver on all commitments

  • Support both site and global process improvement initiatives to the process and tools; creating and providing appropriate metrics to monitor status and timelines
  • Education and Experience :

  • Minimum Bachelors or Masters Degree in Pharmaceutical or Life Sciences.
  • Minimum 10 years’ experience in a cGMP controlled / pharmaceutical industry, including at least 5 years’ experience in management within a Quality environment required.
  • Strong GMP background with thorough knowledge of cGMPs and regulatory requirements required.
  • Experience interacting with Health Agency reviewers / inspectors.
  • Act for Change, Cooperate Transversally, Strive for Results, Thinking Strategically, Commit to Customers, Develop People, Make Decisions, Lead Teams.
  • Ability to work strategically in a fast-paced environment and make balanced decisions related to quality.
  • Ability to effectively communicate (verbally and written) across all levels of the organization, as well as external partners to the site.
  • Strong customer focus and ability to prioritize and adapt to business and manufacturing needs.
  • Sanofi Pasteur : The world’s leading vaccine company

    Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines.

    Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Our company distributes more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe.

    Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases.

    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 is an equal opportunity employer committed to diversity and inclusion. Our goal is to attract, develop and retain highly talented employees from diverse backgrounds, allowing us to benefit from a wide variety of experiences and perspectives.

    We welcome and encourage applications from all qualified applicants. Accommodations for persons with disabilities required during the recruitment process are available upon request.

    Thank you in advance for your interest.

    Only those candidates selected for interviews will be contacted.

    Sanofi, Empowering Life

    GD-SP #LI-SP

    At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers.

    We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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