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Global Head of Compliance Management Job at Quality at Sanofi

Location Lyon, Rhône-Alpes Job Category Quality Requisition Number 40577
Global Head of Compliance Management-40577


Description
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us


Sanofi Pasteur SA and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.



To lead, coordinate, manage, and continually improve compliance activities within Sanofi Pasteur such that products, systems and facilities are in a state of sustainable compliance with the requirements of regulatory authorities worldwide and with Sanofi Quality Requirements. This will be achieved by assuring full responsibility for and leadership of cGMP compliance activities as defined below.


Job Description:


This role has responsibility to define, develop and maintain the Sanofi Pasteur cGMP compliance and quality performance strategy as well as monitoring progress and lead key activities to ensure the company meets the highest quality standards relevant to our business. He or she will also ensure that relevant information and best practices are shared globally and that a continuous improvement towards sustainable practice is established for achieving quality and compliant business. This role also includes active involvement external to Sanofi Pasteur to advocate the company’s view on cGMP compliance and quality performance as it relates to vaccines.


Key Accountabilities:


  • Provide leadership and direction to sites in order to ensure that cGMP compliance activities are understood, prioritized and managed. Ensure strategic compliance through global initiatives and projects, build sustainable compliance processes.
  • Ensure cGMP compliance through leadership for the implementation of the Sanofi Quality System (through clear dialog and clear business processes), setting and monitoring key quality and cGMP compliance metrics and act on these where needed, and through active engagement with other Quality leaders and functions in Sanofi Pasteur and Sanofi.

  • Ensure robust inspection management programs are in place at all sites and provide leadership and coordination for company-wide activities. Responsible for independent compliance assessment of IO and R&D clinical batch manufacturing with Global Quality Directives and Health Authority expectations according to the PMG process.

  • Manage any 3rd party used to support the cGMP compliance activities. Ensure Drug Shortage Prevention Plans are established per company guidelines and priorities.

  • Provide leadership with regards to risk management, escalation & management of critical events and risks globally as well as maintaining emerging risk surveillance.

  • Ensure continuous improvement of material management and efficiency of supply management and supply chain quality.

  • Own the Corporate Quality Council business process and the Quality Management Review process.

  • Build Quality Intelligence and Knowledge Management processes for Sanofi Pasteur and develop network with Sanofi.

  • Work closely with the Responsible Pharmacist organization in all matters related to cGMP compliance and quality performance.

  • External involvement to ensure current and future cGMP and quality requirements are influenced and understood.


Qualifications
Basic Qualifications:
  • Bachelor's degree in Biology, Pharmacy or Microbiology

  • At least fifteen years direct experience in pharma/biotech manufacturing and quality environments/organizations with a history of success in dealing with or working in major Regulatory Authorities, particularly the EMEA, WHO and the FDA. A good understanding of Regulatory Submissions is also a necessity.

Technical Competencies & Soft Skills:
  • Fluent in English
  • Strong ability to lead project with multi-disciplinary and international teams
  • Strong ability to build and drive a network
  • Ability to make decisions in a highly moving environment



Job : Quality
Primary Location : France-Rhone-Alpes-Lyon


Job Posting : Feb 2, 2016, 11:53:28 AM