Manager Supplier Quality Internal Audits – Sanofi Pasteur – Swiftwater, PA, USA
The Internal Auditor is responsible for the auditing of compliance to regulatory requirements, global requirements and internal requirements across Industrial Operations and Regulatory Affairs to ensure GMPs are followed in a compliant manner. The scope of this auditing function includes IO production, testing of license product and RA supporting IO.
The individual is accountable for ensuring a constant state of inspection readiness as it applies to GMP compliance.
Provide quarterly audit reports to the Site Quality Council on audit findings within Industrial Operations
Work with Regulatory Affairs and Industrial Operations management to ensure corrective actions to findings are managed to timely completion
Interact within the Production and Regulatory environments
Interact with regional counterparts on intersite activities relating to manufacturing, testing, disposition and cold chain documentation
Key Technical competencies and soft-skills:
Excellent communication, interpersonal and team work skills
Understanding of vaccines/biologics products and associated technologies
Strong subject matter knowledge in: Audi, Compliance, Manufacturing/Production, Aseptic, Sterile and Lab
Knowledge of Toxicology and cGLP is helpful
Strength in several LEAD Competences-Think Strategically, Lead Teams, Act for Change, Strive for Results, Cooperate Transversally, Commit to Customers, Make Decisions
Who You Are
You are inspired and driven by sanofi pasteur IO mission to improve worldwide human health. You would fit in well with our sanofi values of innovation, solidarity, confidence, respect and integrity and our ways of working (Focus, Agility, Accountability and Simplicity).
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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.
Bachelor’s Degree in life sciences
5-7 years experience in a cGMP or cGLP controlled/pharmaceutical enviornment
5-7 years experience in a regulated Quality environment
Job : Quality
Primary Location : United States-Pennsylvania-Swiftwater