The mission of the External Supply Quality Assurance (ESQA) team is to ensure the quality of Zoetis' animal health products through management of outsourced activities and oversight of third party contract manufacturers, thereby ensuring the reliable supply of quality products to our patients and their caregivers.
Each ESQA Contract Quality Leader (CQL) has the responsibility for the oversight of multiple US/CLAR based contract manufacturing organizations, ensuring global GMP Quality and Regulatory Compliance standards are maintained and the expectations of Zoetis as Marketing Authorization Holder or Distributor are met.
This is a relatively independent position operating with minimal supervision requiring a range of GMP experience and technical knowledge, interacting with high levels of management at contract manufacturers. The ESQA CQL will also be expected to interact with other Zoetis business, supply and manufacturing units and may be involved in cross-functional teams. Each ESQA CQL is expected to be customer and business focused and willing to travel up to 20%. This job can be located anywhere within the US/LAR region.
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 marketed 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 Global Compliance Audit Support.
New Product Introduction: Support Zoetis business development opportunities in selection, due diligence audit and evaluation of potential contractors in the process of New Product Introduction by supplying appropriate quality input.
Product Transfers: Act as Quality subject matter expert for product transfer teams, advising on Zoetis' and GMP expectation regarding process validation and analytical method transfers performed at the 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 and Zoetis Quality Governance models.
EDUCATION AND EXPERIENCE
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