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

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,

• 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

Full time

Regular

Colleague

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at zoetiscolleagueservices@zoetis.com to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.

This job has expired.