Sanofi Group Manager Compliance - Quality Assurance [cGMP pharma-biotech] in Swiftwater, Pennsylvania

Manager Compliance - Quality Assurance [cGMP pharma-biotech]


Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers a broad range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please

Position Summary:

Ensure compliance with cGMP, regulatory and internal requirements regarding the manufacturing, testing and distributing of products through formal QA Audits, investigations, training and recommendations to procedures. Evaluate and provide QA recommendations on all products, systems and issues that are/may be affected by regulatory or cGMP requirements.

Position Responsibilities:

  • Participate in project teams involved with the facilities, processes and equipment for the manufacturing of vaccines

  • Ensure a constant state of inspection readiness and that all audit observations are addressed

  • Interface with FDA and international regulatory bodies during site inspections

  • Review and Close incident investigations including final product disposition decision

  • Provide input and guidance to the team conducting the investigation

  • Make recommendations to department management regarding results of investigation and process improvements

  • Manage our quality systems to ensure that corrective and preventative actions are made

  • Provide support to functional areas regarding the Change Control System

Technical Competencies:

  • Quality Assurance experience in a Pharma/Vaccine production facility

  • Working knowledge of cGMPs and regulatory requirements

  • Knowledge of vaccines/biologics products and associated technologies

  • Previous experience with Drug Substance and/or Drug Product cGMP Facilities

  • The ability to work on cross functional project teams

  • Meet/Exceed project timelines/deliverables

  • Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office

  • Strength in several LEAD Competencies - Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions

Soft Skills:

  • Communication

  • Writing

  • People Skills

  • Analytical

  • Balanced Decision Making

  • Negotiation

  • Organization

  • Detail Oriented

Sanofi Pasteur SA 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



Basic Qualifications:

  • Bachelor’s Degree

  • 5-7 years’ experience in a cGMP production facility

  • Minimum of 2 years in a Quality Assurance role that includes final closure review of deviation/non-conformance investigations and batch disposition determination.

Job: Quality

Primary Location: United States-Pennsylvania-Swiftwater

Job Posting: Sep 12, 2016, 8:35:58 AM

Job Type: Regular

Employee Status: Regular