Site Quality Lead
Zoetis is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on 60 years of experience, we deliver quality medicines and vaccines, complemented by diagnostic products and genetic tests and supported by a range of services. We are working every day to better understand and address the real-world challenges faced by those who raise and care for animals in ways they find truly relevant.Our name, Zoetis (z-EH-tis), has its root in zo, familiar in words such as zoo and zoology and derived from zoetic, meaning “pertaining to life.” It signals our company”s dedication to supporting the veterinarians and livestock producers everywhere who raise and care for the farm and companion animals on which we all depend on.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. 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.POSITION SUMMARY The position reports to the Platform Quality Leader . The Site Quality Lead role is accountable for product quality and the site”s regulatory compliance standing – maintaining a state of Inspection Readiness. The role insures that the Quality Control function meets all regulatory compliance requirements and GMPs. The Site Quality Lead champions the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site. The Site Quality Lead is a member of the GMS Site Leadership Team and participates in setting the strategic direction of the quality unit and the site as well as managing day to day quality operations. The position also co-chairs the site Quality Council (with the GMS Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality improvement initiatives. The role has ownership of the Site Risk Assessment Process – leading the Site Leadership through the process on a predetermined cadence. The Quality Lead uses data and metrics to drive continuous improvement in site quality systems as well as Product Quality. Additionally – the role is responsible for creating and executing the Site Quality Roadmap.
Establishing / Reinforcing the Quality Culture on the Site; Contributing member of the Site Leadership Team Implementation of Quality Standards Maintain Site Inspection Readiness. Promote Compliance Audit findings/remediation. Insure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies) Insure Product Release is done within Regulatory Standards and pertinent Registration Files. Insuring QC Testing meets Regulatory Compliance and GMPs. Proactive Ownership of the Site Risk Assessment process.
Oversee the development and implementation of the Quality Plan / Quality Road Map Share Leadership of Site Quality Councils and Metrics Develop metrics to deliver product and process improvement. Maintain the Supplier Quality program and vendor certification.
Insure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance) Create and be accountable for the Site QA/QC Budget. Champion Leadership Development for the Site Quality Staff.
Overall Site Product Portfolio Quality Stewardship owner and accountability.Staff and Leadership Responsibilities Leadership Development / Coaching of Staff; Creation of Learning Organization Stewardship of the Quality Culture within the QA Function as well as the Site. Insure Training and Development plans are in place for all QA associates. Development of Site QA operations budget and resource planning for roll up to the Site Quality Budget. Support the development of Quality goals and targets as part of the organization”s strategic plan. EDUCATION AND EXPERIENCE
Science or Engineering BS / MS / PhD Demonstrated significant leadership experience in a Quality Role in Animal Health / Human Health / BioDevice manufacturing 7 – 10 years Operations or Quality Experience in Biological and/or Automation Manufacturing FDA, USDA, GMP, ISO regulated work experiences desired Fluent with Six Sigma and/or Lean Manufacturing TECHNICAL SKILLS REQUIREMENTS Does well in a Change Management environment, Acts as a Change Agent Problem solver, root cause analysis methodology Process oriented mindset; data and continuous improvement orientation Able to work well in complex environment Experience in relevant ERP functions PHYSICAL POSITION REQUIREMENTS
Position located in Durham Minimal off-site travel Occasional non-core hour work anticipated ACRONYM DEFINITIONS GMS: Global Manufacturing and Supply GMT: Global Manufacturing Technology USDA: United States Department of Agriculture