Site Quality Systems and Standards Manager
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 SUMMARYSummarize the primary purpose & key accountabilities of the position, including scope of responsibility in 5-7 concise sentences. It may be helpful to complete this section after you have finished the other sections of the document. This position reports directly to the Site Quality Lead with a dotted line to the Zoetis Global Quality Systems & Standards (QSS) Lead, and will serve as the most senior QSS Manager for the Site. Together, with their direct reports, they will serve as a partner alongside other stakeholders to enable the Site to meet its Quality objectives and ultimately the overall Site objectives. The QSS Manager will be the Site Owner of the Quality Management System (QMS). They will be responsible for the execution of all quality related governance aspects for Quality (QA and QC) and Operations at the site.
The Site QSS Manager will have overall responsibility to assure that the Site is compliant and aligned with Zoetis Global QSS. The QSS Manager will lead the Quality System & Standards for the Site, assuring compliance with EU, FDA, USDA or other pertinent regulations. The Manager will be responsible for Systems, Standard Operating Procedures and Tools to be in place and in use as well as being properly maintained. Through the Key Quality Performance Indicator Dashboard, the Manager will monitor Site quality systems performance and facilitate appropriate metrics and communications. The Site QSS Manager is responsible for Continuous Improvement activities through participation in the Site Quality Council as well as administration of the Site Quality Road Map.
POSITION RESPONSIBILITIES In order of importance, list the primary responsibilities critical to the performance of the position. For Staff positions, focus on essential responsibilities that highlight accountability and level of judgment required.Key objectives of this position include: Apply the Zoetis Global Quality Standards and Systems and tools at the Site. Maintain the Site QSS in a state of compliance with all applicable Regulations. Develop and use effective monitoring and controls for key processes and product quality – providing assurance of continued suitability and capability of processes. Through Key Quality Performance Indicator (KPI) Dashboard, monitor Site quality systems performance. Administer Site Quality Management System (QMS) governance through management reviews to ensure its continuing suitability and effectiveness. Implement a quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle. Participate in the Site”s Quality Council. Develop, oversee and monitor the Site Quality Plan/Roadmap. (Site Quality Leader is Accountable, QSS Manager is Responsible) Monitor Internal and External Factors Impacting the Quality Management System (i.e. emerging regulations, innovations that might impact the Site QMS). Lead and oversee Site Quality training plan and establish an appropriate method to check for effectiveness. Ensure that the Site Validation Master Plan is In-Place and In-Use. Oversee and monitor the Site computer system validation (CSV) plans and execution. Provide specific Site Wide data integrity (DI) awareness and training on an annual basis. Ensure GMP documentation is properly managed and archived, Assure the use of operational excellences tools in quality procedures and processes. Support the development of Quality Goals and targets as part of the organization”s strategic plan. Staff and Leadership Responsibilities
* Leadership Development / Coaching of Staff; Creation of Learning Organization * Stewardship of the Quality Culture within the QSS Function as well as the Site. * Ensure Training and Development plans are in place for all QSS associates. * Developing QSS operations budget and resource planning for roll up to the Site Quality Budget.
ORGANIZATIONAL RELATIONSHIPSProvide the primary groups or key positions that this position will have interaction with as a regular part of the position responsibilities. Include any external interactions as appropriate.The QSS Manager will interact regularly with Site Leadership to assure quality goals and objectives are met.Additionally – the Manager will work closely with the Corporate QSS Leader to stay current with all Zoetis QSS practices, systems, and strategies. Other key associations will be with certain members of VMRA and GQCA
RESOURCES MANAGED Financial Accountability N/A Supervision Staff and hourly colleagues (approximately 8)
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.
* Undergraduate degree in engineering, pharmaceutical, or chemistry sciences. * Relevant advanced degree preferred. * 10 years relevant experience in Pharmaceutical and/or Animal Health industry * Working knowledge/fluency of Quality Management Systems. * Demonstrated supervisory skills and experiences