Director of Quality Assurance, Antigen
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Our Sanofi Pasteur Swiftwater, PA site, where we both research and manufacture vaccines since 1897, has had a tremendous impact on global health and the quality of human life. Nestled among the Pocono Mountains in Swiftwater, Pennsylvania, Sanofi Pasteur is home to state-of-the-industry facilities—and a rich and unique history. Our Swiftwater campus is more than 500 acres, housing 44 buildings and encompassing more than one million square feet of building space. Many of our facilities, while bright and modern, still retain the rustic charm of the original stonework.
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Director of Quality Assurance, Antigen
Location: Swiftwater, PA
What We Do
The Director of Quality Assurance, Antigen provides leadership and direction for the Quality Assurance department. This position leads the quality assurance department and guides the quality oversight over viral and bacterial drug substance manufacturing areas, and Quality Control.
This role provides leadership and direction for quality oversight of the vaccine drug substance manufacturing. This leadership role collaborates with a group of highly skilled and technical colleagues toward an inspiring mission of creating high quality life-saving vaccines.
Where We Are
The site is located in Pennsylvania, 90 miles west of New York and less than 12 miles from the New Jersey Border, the Swiftwater site is Sanofi Pasteur’s US headquarters shared by Commercial Operations, R&D, Regulatory Affairs and Industrial Operation teams. The 500-plus acre campus consists of 40 buildings and 14 modular buildings, housing more than 2,700 employees, including nearly 1,600 employees in Industrial Operations. The Site is located in the beautiful Pocono Mountains, affordable Northeastern Pennsylvania with convenient highway access.
*Leads the Quality Assurance team supporting viral and antigen production, as well as QC. Ensures the QA team is properly staffed, trained and organized to provide exceptional risk-based quality oversight.
*Build and maintain a high performing team, providing effective alignment and communication with cross functional groups at the site to successfully deliver on all commitments
*Ensures assigned areas consistently meet current FDA regulations, International Health Authority regulations, and company policies, procedures, and standards.
*Keeps assigned areas constantly inspection ready and ensures audit commitments are completed on time.
*Ensure assigned areas have established processes to effectively manage deviations, CAPAs, change controls and other quality system requirements on time.
*Establishes departmental objectives to align with site objectives for safety, quality, productivity, cost, and continuous improvement
*Bachelor’s Degree in life sciences or related science degree.
*10 years’ experience with cGMP regulated vaccine or Biological Drug substance in a, Pharmaceutical or Biotech industry.
*5 years’ experience leading teams in a GMP regulated environment is required.
Terms of employment
< 10% travel. Domestic and International travel
Sanofi Inc. 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.
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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