Manager Quality Validation - Vaccine
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Manager Quality Validation(Swiftwater, PA)
- To provide Quality & Compliance oversight to site qualification and validation projects
-This position has signatory responsibilities for all qualifications/validation issues associated with assigned area(s).
-The individual will participate in project teams and will review and approve qualification and validation related documentation for assigned areas including but not limited to Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs, PQ and PV.
-Accountable for the qualification and validation of 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 quality compliance leadership, within the realm of qualifications and validation, procedural changes.
-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.
-10 years experience in a GMP regulated environment working on qualification and validation projects associated with Pharmaceutical or biotech processes.
-Must have an understanding of vaccines/biologics products and associated technologies
-Excellent communication skills and teamwork are a must, as individual will be working with various areas throughout Industrial Operations and Regulatory Affairs. Good interpersonal and influencing skills are important for a candidate’s success in this role.
-Knowledge of current FDA regulations and industry guidance related to validation processes.
-Ability to work in a fast paced environment.
-Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
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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