Sanofi Group Manager Quality Validation CSV in Swiftwater, Pennsylvania
Manager - Quality Validation CSV
(Swiftwater, PA) This position is responsible for providing Quality & Compliance oversight to site Computer System Validation projects. This position is responsible for ensuring the site policies and regulatory requirements are followed for CSV projects on site.
*The individual will participate in project teams and will review and approve computer validation related documentation for systems including but not limited to: criticality assessments, validation plan, user requirements, specifications, UAT, qualification/validation protocols and reports.
*Knowledge of 21CFR Part 11, Annex 11 and GAMP V
*Understanding of GxP regulations and computer validation principals
*Understanding of software development lifecycles
*Understanding of document management principals
*Demonstrated technical writing and oral communication skills.
*Scientific education or experience, with test script design, technical document reviews preferred
*Knowledge of cGMPs and regulatory requirements Strength in several LEAD Competencies-Think Strategically, Act for Change, Strive for Results, Cooperate
*Transversally, Commit to Customers, Make Decisions
*Bachelor’s degree in Engineering, Computers or related field.
*5+ years in a GMP regulated environment working on computer system validations
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.
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, Empowering Life