Site Quality Systems and Standards Manager
Zoetis

Job Info

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POSITION SUMMARY

This position reports directly to the Site Quality 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

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. POC for all QMS audits and regulatory inspections. Develop and use effective monitoring and controls for key processes and product quality - providing assurance of continued suitability and capability of processes. Monitor site Quality System performance through established key quality performance indicators (KPI). Facilitate site management review process to ensure the effectiveness of the site management review. assess the quality systems' s continued 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) Lead and oversee Site Quality training plan and establish an appropriate method to check for effectiveness. Lead and oversee document control, CAPA, NCRs, Training, Change Control and Supplier Management 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 organizations 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 RELATIONSHIPS

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.

EDUCATION AND EXPERIENCE

• Undergraduate degree in engineering, pharmaceutical, or chemistry sciences.
• Relevant advanced degree preferred.
• 10 years relevant experience in Medical Device/In Vitro Diagnostics and Animal Health industry
• Working knowledge/fluency of Quality Management Systems, 21 CFR Part 820, ISO 13485 and ISO 14971
• Demonstrated supervisory skills and experiences.

TECHNICAL SKILLS and COMPETENCIES REQUIRED

• Ability to lead a site quality systems and compliance organization.
• Driven / Passionate about Quality performance and delivering results.
• Sets Clear Direction and Aligns Team and Others Around Common Objectives
• Ability to coach and develop a strong leadership team.
• Inspires Continuous Improvement and Breakthrough Thinking
• Exercises Good Judgment and Drives Change - using appropriate influence techniques.
• Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with Site and Corporate objectives
• Strong written and oral communication skills
• Proficient in English
• Demonstrated skills in presenting to leadership teams.
• Business Fluency and Ability to be a Trusted Partner

PHYSICAL POSITION REQUIREMENTS

• Union City, California Site based position
• This position will require fluent use of teleconferencing and Webex tools, as well as SharePoint technologies, to share and manage information with Global Quality Centre Organization and other Zoetis internal manufacturing network

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.

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