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
- Assure the release activities are part of a quality system based on defined standards and processes, e.g., SOPs, training, deviation handling, complaints handling, GMP/GDP documentation, notification procedure, archiving, retention samples.
- Manage any deviation, compliance gap and product defects complaint related to these products, in coordination with the persons responsible for managing quality and compliance of the manufacturing sites
Reconditioning of product
- Manage quality approvals and issues at the reconditioning contractor to enable product reconditioning in compliance with national requirements.
- Provide Zoetis approval for Batch protocols where required
- Zoetis Quality oversight of product reconditioning operations (CAPA's. complaint management etc.)
- Negotiate the quality agreements between the contract giver and the contract acceptor which specifies their respective responsibilities.
Quality Management systems
- Assure Good Distribution Practices are in line with standards
- Ensure that a quality management system is implemented and maintained for supporting US release and distribution activities. Participate in developing SCL Guidelines to ensure consistency of standards across Zoetis
- Participate in Coordination of Global Compliance Quality Audit (GCQA) audit schedule for all warehouses in the US distribution network
Transportation and temperature excursions
- Act as sending or receiving site quality authority for temperature excursions during transportation.
Other
- Be a Zoetis representative during competent authority audits of Zoetis operations at Zoetis owned logistic centers.
- Ensure any impact on Zoetis product is communicated in a timely manner.
- Where identified by other means, e.g. Quality visit, complaints etc., propose potential GMP Improvement plans for contracted 3rd parties and assist with the implementation
Education:
- Bachelor's degree in a Life Science, Pharmaceutical Science, Veterinary, Chemistry, Biology or equivalent.
Experience:
- Approximately 10-15 years of relevant operational experience in quality operations within animal health and/or pharmaceutical industry. Experience in logistics operations is a plus.
Skills:
- Proven leadership skills and good matrix management skills
- Good negotiation and influencing skills
- Strong project management, writing and presentation skills.
- Good problem-solving skills
- Strong knowledge of Quality Management System processes, GMDP
- Able to work independently and effectively interact with various levels of staff and management
- Proven ability to work with senior leaders in Commercial, Regulatory and Supply Chain and Logistics
- Proven understanding of manufacturing processes and logistics operations
- Experience working with and interacting with various regulatory agencies
- Strong written and oral communication skills
- Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with division and corporate objectives
- Ability to analyze data and synthesize to investigate and make data driven decisions and CAPA
- Proficient in English
- Good skills on Microsoft office tools
- Experience in SAP, Event Tracking System (ETS) and Veeva Vault is a plus
About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
Diversity, Equity & Inclusion
Connected to our purpose and Core Beliefs, at Zoetis, we lead with inclusion. Our Diversity, Equity & Inclusion (DE&I) focus helps create an environment where each colleague can thrive. Our commitment to DE&I begins with our leadership team of diverse backgrounds, experiences and ethnicities, and it is demonstrated in our support of our colleagues and the animal health industry. We have nine colleague resources groups whose members spread awareness, foster inclusivity and make a positive impact on our business and communities.
Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a 2024 Catalyst Award recipient and a Top 50 Company for Workplace Fairness by Fair360 (formerly DiversityInc). Zoetis has also been named a Best Place to Work for LGBTQ+ Equality, a Best Company for Working Parents, a Top Company for Executive Women, among many others. Learn more here.
Global Job Applicant Privacy Notice