Sanofi Group Manager Quality Validation [cGMP pharma-biotech] in Swiftwater, Pennsylvania
Manager Quality Validation [cGMP pharma-biotech]
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. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.
Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. We distribute more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Our company has more than 13,000 employees worldwide working in 14 production and/or R&D sites with more than 50% of staff devoted to industrial operations (IO). Industrial Operations (IO) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi Pasteur provides associates in IO a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education.
This position is responsible for providing Quality & Compliance oversight to site validation projects related to Bacterial Vaccine Manufacturing.
The individual would be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Bacterial Vaccines and will review and approve validation related studies for assigned areas.These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management.This position has signatory responsibilities for validation/qualification documents within assigned areas.
Knowledge of current FDA regulations and industry guidance related to validation processes.
Experience with validation of biotech manufacturing processes (i.e. viral antigen production)
Knowledge of vaccines/biologics products and associated technologies
The ability to work on cross functional project teams
Meet/Exceed project timelines/deliverables
Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office
Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
Sanofi Pasteur SA is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment regardless of their race, color, religion, sex, national origin, or any other characteristics protected by applicable law.
Basic Qualifications :
Bachelor’s Degree in Science OR Engineering
3 years’ experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment.
Primary Location: United States-Pennsylvania-Swiftwater
Job Posting: Sep 27, 2016, 9:22:35 AM
Job Type: Regular
Employee Status: Regular