As a member of the Quality Operations, Operational Quality team, provide compliance support to Deputy Directors for the licensed product, teams in managing their day-to-day operations in compliance with Sanofi Pasteur quality systems requirements and Good Manufacturing Practices. The incumbent will provide Operational Quality support Deputy Directors for designated departments of Industrial Operations (such as: Bulk Manufacturing, Formulations Filling & Packaging, Media Services, Manufacturing, Quality Control, Global Engineering Maintenance, Materials Management/Logistics, Purchasing and Customer Service/Marketing, Manufacturing Technology, QOSA). The incumbent is expected to work independently as a QO Manager with a level of autonomy and authority for decision making as a delegate to the Deputy Director as necessary to drive process improvements, ensure ongoing compliance to requirements in the dossier, current GMPs, and also achieve process efficiencies.
Major Duties and Responsibilities
- Support the Operational Quality Deputy Directors in ensuring timely review, follow-up on, closure and approval of various documents, such as: master and executed batch records, operational log books, sterilization and depyrogenation records, SOP, SWI, deviation, protocols, reports, work orders, worksheets, maintenance task lists, that are within the scope or delegated.
- Ensure failure investigations/deviations are processed and that problem resolution occurs prior to commitment date within SAP. Ensure that batch recommendations are based on sound science and supporting reports are of high quality. Ensure timely review of deviation, and approve notation and minor deviations.
- Perform the role of QO Representative in coordinating, investigating and assessing Change Control Requests (CCR’s) and CAPA for IO, as designated within this process. This activity will require the incumbent to determine if a change request impacts product and processes.
- In addition, the incumbent might have to be a QO Representative at various internal and external committees and board related to the management of the organization, such as: Sanofi Pasteur Change Control Board, Material Review Board.
- Ensure through shop floor presence and knowledge transfer, that there is in-depth GMP understanding as it pertains to specific operations and that issues are identified locally and dealt with through close contact with the various departments.
- In conjunction with the QO Quality System Internal Auditor and Vendor Auditor, perform audits and support functions performing GMP activities to ensure compliance with cGMP standards, site and corporate policies.
- Develop tools for performance monitoring and provide feedback to the departments supported both formally (departmental presentations) and informally (shop floor review) and obtain agreement on corrective actions as required.
- Make assessment decision and authorization for processing / reworking, manufacturing at risk.
- Perform data gathering and analysis of non-conformances to support annual product review.
- Project team participation
Education and Experience
- Master of Science specializing in Microbiology, Biochemistry, Immunology or Pharmacology with 8 or more years of relevant experience in pharmaceutical or biological manufacturing.
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
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.