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.
Position Summary: The Corporate Sterility Assurance Director will have responsibility for providing leadership and expertise for Sterility Assurance by ensuring systems and procedures are defined, understood, implemented, and validated globally. The successful candidate will have a strong vision for the program and ways to implement industry best practices, regulatory guidelines, and corporate directives on sterile manufacturing.
Position Responsibilities: Lead execution of company-wide standardization and continuous improvement for Sterility Assurance through direct interaction with sites and global experts. Ensure that manufacturing practices are aligned with internal and external guidance. Coordinate decision-making that establish global policies affecting business plans, departments, resources or products across multiple sites while avoiding significant and costly errors. Be recognized as a technical expert with understanding of sterile manufacturing, aseptic processes, microbiological testing and environmental monitoring.
Technical Competencies:Knowledge of quality and technical regulations that govern a cGMP environment.The ability to work on cross functional project teams and foster effective working relationships with all levelsSelf-directed and able to work independentlyMeet/Exceed project timelines/deliverablesPrior experience in Pharmaceutical Industry Committees or working groups is desireableExperience communicating with senior management and regulatory agencies · 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.
Bachelor's Degree in Microbiology, Pharmaceutical Science or related biological subject10+ years of relevant experience in Pharmaceutical/Biotech Sterile Manufacturing or Quality environment.