Manager of Quality Operations
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 Responsibilities 1. Purpose or objective: * Working with the site leadership team, the Manager of Quality Operations role will ensure that Zoetis San Diego manufacturing facility is in compliance with USDA regulations, ISO guidelines, and other applicable regulations or guidelines. * The role is responsible for planning, coordinating, delegating, and completing submissions and necessary licensure on existing product line improvements. * The role is accountable for product quality and sites quality compliance standing. * The role is responsible for the quality supplier audit program. * The individual is responsible for the direction of 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. * The individual will serve as the USDA Liaison and as the Management Representative for ISO 9001:2015 Certification. * This position is responsible for reporting to the Quality Platform Leader all issues which impact or could impact marketed product including headcount and budget constraints. * The Manager of Quality Operations champions the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site. * The Manager of Quality Operations 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 position also co-chairs the site Quality Council (with the Site Head) 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 Manager of Quality Operations 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. * Perform other duties as required. 2. Essential functions or specific 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. * 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 – 20%, QA Functions – 50%, QC Functions – 25%, Misc. duties – 5% Education and Experience * 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. Technical Skills Requirements * 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 Position Requirements * Occasional lifting up to 30 pounds. * Frequent bending, walking and stopping within a manufacturing environment; significant computer usage requirements. * Travel required including International travel. Typically less than 5% but at times may exceed including weekend stays.