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Site Quality Lead

Company: Zoetis Animal Health
Location: Union City
Posted on: October 14, 2020

Job Description:

POSITION SUMMARY - Site Quality Director role is accountable for leading all Quality functions at the site including quality assurance, quality control, quality operations, and compliance. The role achieves site and corporate quality objectives through leadership, development, and coaching of staff and assures systems and processes are in place to meet or exceed Zoetis and regulatory requirements insures that the QC function meets all regulatory compliance requirements and GMPs. As such, the Site Quality Director is designated as the Management Representative in accordance with 21 CFR Part 820 and ISO 13485 and will ensure that the Zoetis manufacturing facility is in compliance with USDA regulations, ISO guidelines, and other applicable regulations or guidelines. The role is accountable for: - Planning, coordinating, delegating, and completing submissions and necessary licensure on existing product line improvements. - Ensuring product quality and the sites quality compliance standing. - Directing the Quality Assurance and Quality Control departments to ensure these departments fulfill the requirements of the company and comply with product registrations and current regulatory requirements. - Serving as the USDA Liaison and as the Management Representative for ISO 9001:2015 Certification. - Reporting to the Quality Platform Leader all issues which impact or could impact marketed product including headcount and budget constraints.The Site Quality Director champions the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site. The role is accountable to ensure the site Quality Policy is understood, implemented and maintained at all levels of the site organization. The Site Quality Director role is responsible for ensuring the independence and authority of the Quality unit is maintained and for ensuring adequately trained resources are available to support the quality system. The Site Quality Director is a member of the 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 Site Quality Director role is accountable for ensuring an annual site Quality Plan has been established; Standard Operating Procedures and instructions have been established; and, a plan for Quality Audits has been established and maintained. - Ownership of the Site Risk Assessment Process leading the Site Leadership through the process on a predetermined cadence. - Utilizing 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. POSITION RESPONSIBILITIES - Direct Quality resources to facilitate the availability of quality products at all times. To achieve this objective, planning and communication with various groups across the organization is required Maintain the Supplier Quality program and vendor certification. - Insure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance) - Develop metrics to deliver product and process improvement. - Champion Leadership Development for the Site Quality Staff. - Overall Site Product Portfolio Quality Stewardship owner and accountability - Is involved in new product development, product improvement, cost improvement and existing product maintenance. - Prepare and maintain annual budget for department. Critical regulatory / quality decision are made at this level with input from upper management as required. - Regulatory Functions - 25%, QA Functions - 25%, QC Functions - 25%, ; Quality Operations 25%. - Realignment strategy deployment and culture change expertise. - Manage budget of up to $2M per year in addition to personnel costs. Responsible for insuring plant stays in compliance with all applicable USDA, local, county, state, federal and international entities so as to insure continuous supply of products to meet sales goals. - Manage salaried managers engaged in Quality Control, Quality Assurance, Quality Operations and Compliance. 6 direct reports and 3 indirect. - Interact daily with plant personnel in all disciplines. - Interact routinely with various Zoetis outside functions including but not limited to Quality Operations, Regulatory Affairs, R & D, Sales, Procurement, EHS, Human Resources, Global QSS, Corporate Quality Auditing, Operational Excellence and BT. - Interact as needed with the USDA & FDA. FDA contact is limited but may be necessary to clarify oversight which is by the USDA. - Share Leadership of Site Quality Councils and Metrics EDUCATION AND EXPERIENCE Indicate the formal education, certification or license required and/or preferred. Include the minimum number of years of relevant experience required for the position. - Four-year degree required with an emphasis in science, animal science or veterinary is preferred as well as 5-10 years of experience in a Regulatory Affairs and/or Quality Assurance - Capacity. Post-graduate coursework with an emphasis towards RA and QA is beneficial. Previous experience in an in vitro diagnostic production facility is highly beneficial. - Science or Engineering BS / MS / PhD - Demonstrated significant leadership experience in a Quality Role in Animal Health / Human Health Medical Device and In Vitro Diagnostics - Operations or Quality Experience in Medical Device and In Vitro Diagnostics - FDA, USDA, and EU regulated work experiences desired - Fluent with Six Sigma and/or Lean Manufacturing - Strong experience in 21 CFR Part 820, ISO 13485 and ISO 14971 principles TECHNICAL SKILLS and COMPETENCIES REQUIRED - To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. - Ability to effectively use and review application of scientific methods required. - Ability to effectively review validation proposals and reports for adequate technical justification of conclusions. - Ability to effectively review in-process and product final testing to insure compliance with requirements. Ability to effectively identify additional testing requirements and analyze results when product testing does not fall within required limits or when other information calls in to question a products adequacy for use. - Ability to identify testing requirements for new and or improved products with the aid of PDPI and VMRD colleagues. - Ability to effectively organize process audits to insure a high level of compliance. - Strong computer skills including Outlook, PowerPoint, Excel, Word. - SAP, Vevva Vault, and ETS experience a plus. Previous LIMS implementation a plus Physical Requirements: While performing the duties of this job, incumbent must be able to access all areas of the facility, and utilize certain Personal Protective Equipment including, but not limited to, hard hats, safety shoes, eye protection, gloves, and/or protective clothing. Job will entail occasional lifting of up to 30 pounds; frequent bending, walking and stopping within a manufacturing environment; significant computer usage. Travel is required including International travel, typically less than 5% overall, but at times may exceed including weekend stays. This description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. Incumbent may be asked to perform other duties as required. Additional position specific requirements/responsibilities are contained in approved training curricula. Full time Regular Colleague 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 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 site, or (2) via email to/from addresses using only the Zoetis domain of @. 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.

Keywords: Zoetis Animal Health, Union City , Site Quality Lead, Other , Union City, California

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