Manager Quality Validation-Swiftwater, PA

Job description

Manager Quality Validation (Swiftwater, PA)

This position is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.

Key Accountabilities:

The individual will be part of the Site Quality Organization and will participate in project teams involved in site biotech facilities, processes and equipment for the manufacture of Drug Substance and/or Drug Product Vaccines. In this role, the individual will review and approve validation related studies for assigned areas. These assigned areas would include validation lifecycle activities such as Validation Planning, Biotech Process Validation, Equipment and Facility Qualification and Validation Risk Management. This position has signatory responsibilities for validation/qualification documents within their assigned areas.

Candidates should have experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processes.

Excellent communication skills and teamwork are a must, as individual will be working on cross functional project teams which include members from various organizations within Sanofi Pasteur such as Manufacturing Technology, Engineering and Regulatory Affairs. Good interpersonal and influencing skills are important for a candidate's success in this role.

Basic Qualifications:

Bachelor's degree in Engineering, Science or related field.

3-5 years in a GMP regulated environment working on validation

Experience working on cross-functional teams

Experience leading quality validation projects and/or teams or acting as a SME for other internal groups

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.

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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.