Manager - External Supply Quality Assurance
- Contractor Management: Own and manage the contractor relationship for Quality and Regulatory compliance to ensure contractors have applicable quality systems, comply with GMP/regulatory requirements and Zoetis expectations for products. Routine oversight includes responsibility for Quality Agreements, Change Control, Deviation Management, Market Actions, Lot Approval Complaint Handling, Annual Product Review, Stability Studies, Validation Approval and Audit Support;
- New Product Introduction: Support Zoetis business development opportunities in selection, audit and evaluation of potential contractors in the process of New Product Introduction by supplying appropriate quality input;
- Product Transfers: Act as Quality support for Product transfer team, advising on Zoetis and GMP expectation regarding process validation and analytical method transfers performed at contractor;
- Regulatory Compliance: Support and/or conduct Regulatory compliance assessments at contractors. Facilitate the process of documentation retrieval and collation to support Marketing Authorization renewals and variations. Act as QA focal point for regulatory communications and changes;
- ESQA Quality Systems: Contribute to the maintenance and development of the ESQA Quality System.
EDUCATION AND EXPERIENCE
- Bachelor/Master degree in Pharmaceutical Science, Microbiology, Chemistry or equivalent;
- Minimum 10 years’ experience in Pharmaceutical industry, with at least 6 years in a QA/QC role supporting commercial pharmaceutical operations;
- Fluent in English (written and spoken) and ideally knowledge of one or more European languages.
TECHNICAL SKILLS REQUIREMENTS
- Demonstrate knowledge of a range of products and regulatory requirements in the diverse portfolio of products (ideally including Animal Health);
- Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor. Prepared to take initiatives with an ability to handle and prioritize issues accordingly as they arise;
- Ability to prioritize workload to act and work independently, a confident decision maker with the ability to recognize significant issues requiring immediate reporting to the Team Leader;
- Diplomatic in communication with internal and external stakeholders, strong negotiating skills and a demonstrated ability to resolve conflict to the benefit of all parties.
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