Senior Supply Quality Manager

2 weeks ago


Madison, Wisconsin, United States Catalent Inc Full time
Responsibilities and Requirements
As a Supplier Quality Regional Lead, you will be responsible for managing the regional Supplier Auditor Team and appraisal processes, ensuring supplier integrity and oversight. Key responsibilities include:
- Oversight and leadership for the regional Supplier Auditor Team performing audits and generating audit reports
- Management of supplier CAPA (Corrective and Preventative Action) to ensure required actions are completed within the required timeframe
- Support to Supplier Quality site teams on routine queries and guidance

Requirements
- Bachelor's Degree, required; Certified auditor or lead auditor credentials, preferred
- Five years+ auditing experience and supervisory experience, required
- Experience working in an auditing role within the Pharmaceutical/Medical Device industry
- Knowledge of EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices

Why Catalent?
Catalent is a global leader in contract development and manufacturing, committed to delivering unparalleled service to pharma, biotech, and consumer health customers. Our mission is to develop, manufacture, and supply life-enhancing and life-saving treatments for patients worldwide. We offer a comprehensive benefits package, opportunities for professional growth and development, and a collaborative and dynamic work environment.

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