Sanofi Group Manager Quality Validation - Vaccine in Swiftwater, Pennsylvania
Job Title: Manager Quality Validation - Vaccine
*Monday-Friday- 1st shift*
Accountable for the qualification and validation of Cleaning equipment and process, which includes the review and approval of documentation (Datapacks, Reports, Records, Procedures, and Commissioning) to ensure compliance to Global Quality Directives, industry standards (i.e GAMP, ICH, ANNEX), Code of Federal Regulations, and SANOFI site standards.
Accountable to provide cleaning quality compliance leadership, within the realm of qualifications and validation, procedural changes, to support multidisciplinary project teams on the basis of the Site Cleaning Validation Program.
Accountable for cleaning oversight and governance of the site Cleaning Monitoring Program.
Accountable for ensuring the quality compliance of cGMP, FDA and EU regulatory agency and internal requirements regarding the manufacture, testing, and distribution of Sanofi products, through formal Quality audits, investigations, internal and external regulation inspections, training, and recommendations to procedures
Bachelor’s Degree in the field of Science or Engineering
5 - 10 years’ experience in a regulated environment
Cleaning validation projects associated with Pharmaceutical or biotech processes.
Experience working in a cGMP environment
Knowledge of current FDA regulations and industry guidance related to validation processes
Mechanical or chemical background
Ability to work on cross-functional project teams including Manufacturing Technology, Engineering and Regulatory Affairs
Ability to work in a fast paced environment
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.