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Manager - Quality Validation (Swiftwater, PA) - Vaccine

Swiftwater, Pennsylvania



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This position requires project and licensed facility management to ensure that the Qualification, Validation, Re-validation, and Documentation of equipment and processes adhere to the Global Quality Directives, Industry Standards (i.e GAMP, ICH, ANNEX), Code of Federal Regulations, and SANOFI site standards.  This position requires evaluation to ensure SANOFI adhere to revisions to Industry Standards (i.e GAMP, ICH, ANNEX) and the Code of Federal Regulations.

Responsible for being a technical and ensuring the compliance of GMP/GLP, FDA and EU regulator and internal requirements for site

Key Accountabilities:

  • This position has signatory responsibilities for all qualifications/validation issues associated with assigned area(s).

  • Participate in design, review and final approval of qualification and validation activities (i.e. strategies, protocol, reports and data pack), including representation on project team(s) and FFAST Teams.  

  • Responsible for communicating deficiencies to management, recommend corrective actions and perform necessary follow up. Individual will also be expected to support activities relating to protocol deviations, the CAPA system, the Change Control system and incident investigations

  • Provide technical subject matter guidance within the department in ensuring departmental objective align with the site vision for quality and safety, through continuous training, familiarity with current industry practices, and team involvement

  • Supporting regulatory inspections for successful audits.

Basic Qualifications:

  • Bachelor’s Degree in the field of Science or Engineering. 

  • 5 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

Preferred Qualification:

  • Knowledge of current FDA regulations and industry guidance related to validation processes.

  • Ability to work in a fast paced environment.

  • Technical Competencies:  Strong technical background and knowledge in both FDA/EU quality compliance requirements and validation requirements.

  • Soft Skills: Excellent interpersonal and influencing skills and must be able to work in a cross-functional team-based 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.




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