Performance & Customer Center of Excellence Regional Quality Lead – U.S.

POSITION SUMMARY

• Report to the Performance & Customer Center of Excellence (P&C COE) Global Quality Lead within the Global Quality, EHS and Sustainability organization.
• Is a relatively independent position operating with minimal supervision with a range of experience and technical knowledge, interacting with high levels of management
• Lead a team based in the US responsible for Quality Assurance (QA) oversight for warehousing, product reconditioning, distribution and supply chain operations within the US distribution network, including Zoetis owned logistics centers as well as Logistics Service Providers (LSPs).
• Assure compliance to GMDP regulations and Zoetis policy standards for Supply Chain and Logistics operations and associated processes, including importation & release, warehousing and distribution, reconditioning of products, market transfers, management of external relationships with Suppliers
• Drive Zoetis global quality policies and procedures in order to optimize overall quality and compliance performance and to enhance Zoetis compliance, business reputation and relationships with regulatory authorities
• Continuously seek opportunities to improve existing systems, processes and performance within distribution hubs and local market logistics service providers
• Define and continually update strategies and plans to achieve objectives
• Actively engage in market supply and delivery issue management, escalating appropriate issues to P&C COE Global Quality lead in time to ensure necessary remedial actions
• Maintain good working relationships with Commercial, Regulatory, Quality and P&C COE colleagues to reach common objectives

This position is an office-based role located in Parsippany, NJ, with approximately 20-25% travel expected.

Position Responsibilities:

Logistics management at Zoetis owned logistics centers (LCs) and Logistics Service Providers (LSPs)

• Act as the Quality authority at the LCs for distribution in compliance with applicable USDA, FDA and Good Distribution Practice regulations for products and manage the quality management systems and their operations
• Manage the quality requirements for distribution, transportation, and storage activities managed by third parties, including oversight of contracted 3rd party logistics service providers.  Assure Good Distribution Practices are implemented including management of investigations, CAPAs, Complaints, recalls, returns and other quality events/issues at 3rd party LSPs
• Manage the quality requirements for export, to other global markets
• Work with the Sites, SCL, LSPs and Affiliates, to ensure that products are shipped and handled in a compliant and efficient manner
• Maintain a robust system for SOP management compliant with regulatory expectations and Zoetis policies
• Performs necessary functions to maintain correct material and lot status within SAP
• Collaborate in the coordination and completion of any recall operations, following Global and local guidelines and procedures
• Assure qualification and approval of suppliers and customers
• Ensure validated Temperature Control and Cold Chain systems are implemented and maintained
• Ensure that self-inspections are performed at the Logistic Centers at appropriate regular intervals following a prearranged programmed and necessary corrective measures are put in place
• Be involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products
• Supports Quality Assessments/ audits against Quality Standards working towards BoH inspection readiness.
• Develops training packages to increase awareness and understanding GDP and associated processes, for roll out to all colleagues in Zoetis operations, Contract Packaging & labelling and third party LSPs/ Contract Service Providers (transporters, customs brokers)
• Participate in cross-functional project teams for process improvements (i.e., OpEX, Process Excellence and Global Alignment meetings)
• Negotiate the quality agreements between the contract giver and the contract acceptor which specifies their respective responsibilities relating to wholesale distribution and/or transportation of medicinal products.
• Point of contact for quality Zoetis audits and follow up to support contractor development and implement audit action plans in a timely manner, based on existing procedures and practices.

Imported Products and Administrative Release

• As Quality responsible,

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