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Site QA Operations Sr. Manager

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

Job Description:

POSITION SUMMARY This position reports directly to the Site Quality Lead and will serve as Quality Assurance (QA) Operations Manager for the Site. This role has primary responsibility for the establishment, maintenance and overall quality assurance of the warehousing, manufacturing, packaging, and materials management processes. The Manager will provide in plant/on floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations. In supplying the warehouse, manufacturing,packaging and materials operations Quality oversight the WHY as well as the HOW Quality is applied is central to the role. Acting as a Business Partner at all times, ensure all Site Quality Objectives are met and the Site remains in a state of compliance with all applicable requlations. Key processes that the QA Manager has ownership of includes: materials controls, including supplier controls and quality agreements, warehousing, storage and assignment to manufacturing; manufacturing operations, including in-process and finished product quality assurance, quality oversight of validation master plans (VMP), equipment qualifications, calibration and maintenance; quality review of executed batch records; and, quality leadership, oversight of non-conformances/events/CAPA,; and support complaint investigations. The QA Manager will be responsible for leading a team of QA associates that have Quality oversight roles throughout the Site. The Manager will provide coaching/feedback to enhance the group and individuals professional performance and development. The Manager will also keep succession plans updated to minimize hiring lags as roles become open in the group. The Manager will periodically review the groups training record to maintain adequate competency. The QA Manager will serve as a strategic partner alongside other business stakeholders to enable site objectives by meeting quality objectives. POSITION RESPONSIBILITIES Key responsibilities of this position include: - Provide QA oversight and support for Operations in the following key area/activities: manufacturing across all phases of development and commercial manufacture, warehousing, packaging and materials management on site. - Provide in plant/on floor support and guidance for GMP product quality assurance and compliance for Manufacturing Operations. Supply manufacturing and packaging operations Quality oversight supplying the WHY as well as the HOW Quality is applied. Act as a Business Partner at all times while ensuring all Site Quality Objectives are met and the Site remains in a state of compliance with all applicable requlations. - Responsible for preparation and maintenance of the site Validation Master Plan in line with current requirements. The VMP must be established and kept up to date by the local site owner of the operation (e.g. head of manufacturing/technical services) and the responsible Quality Operations, Quality Systems and Quality Control managers. - Provide Quality oversight of qualification protocols and reports. - Ensure Quality oversight of equipment calibration and maintenance reports. - Co-ordinate QA functions for assigned areas of responsibility and provide for QA Operations liaisons with functional departments in Production, Quality and Commercial. - Responsible for leading Manufacturing/Event Investigations (including those related to complaints and non-conformances) and Correctve and Preventative Action (CAPA) Triage meetings, where necessary. - Responsible for scheduling and conducting/leading compliance walk through audits of the manufacturing site. - Provide QA assessment on process related change controls as well as approve change plans. - Assure that all activities related to manufacturing and packaging processes comply with cGMP, applicable regulations and Zoetis Global Systems and Standards. - Responsible to ensure the batch records are complete . - Write, Review and/or Approve GMP procedures related to materials management, storage, dispensing, manufacturing and packaging. - Identify and communicate potential compliance gaps / risks to management. - Provide QA support to the validation function; participate as a representative in project teams concerning facilities, equipment, utilities, cleaning and process validation. - As needed, assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification including change control, and support of site programs.Participate in internal and/or external audits programs. - Participate in inspection readiness and preparation activities, including frontline and backroom support during regulatory site inspections. - Responsible for serving as the QA contact for design change and risk assessment, including cooperating with manufacturing operations on the transfer of those changes into production. - Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology. - Understand and support business needs, provide quality guidance and facilitate resolution of quality issues in a timely manner. 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 organisations strategic plan. ORGANIZATIONAL RELATIONSHIPS This position will need to achieve results through colleagues with a direct reporting relationship (QA team) as well as indirectly with Operations and Functional Site members. The Role interacts regularly with leadership at the site, particularly site Quality and Functional Leads, as well as Zoetis Global functions, including Global Quality Systems and Standards, Global Regulatory Affairs and Global Manufacturing Technology (GMT). EDUCATION AND EXPERIENCE - Undergraduate degree in pharmaceutical, biological, chemical sciences, or engineering. - Relevant advanced degree preferred. - Supervisory experience 5 or more reports; 5 or more years - QP Eligibility advantageous. - Minimum of 8 years progressive experience in the quality control, quality assurance, manufacturing function, or release roles supporting commercial registered product operations for animal health or human health medical devices and in vitro diagnostic products. - Detailed knowledge of cGMPs and demonstrated leadership of Regulatory Inspection Management and Regulatory Affairs. - Knowledge / Expertise in Medical Device and In-Vitro Diagnostic Manufacturing. - Lean Six Sigma Qualification (Green Belt or Black belt) desirable. - Success in maintaining Quality Systems and Standards at manufacturing site level in accordance with 21 CFR Part 820 and ISO 13485 key principles. TECHNICAL SKILLS and COMPETENCIES REQUIRED - Ability to develop and build a strong leadership team which can support the business. - Strong negotiation and communication skills. - Excellent organization skills. - Confident decision maker, self-accountability with an ability to develop and adhere to self-directed standard work. - Sets Clear Direction and Aligns Team and Others Around Common Objectives. - Ability to manage multiple projects simultaneously and prioritize work, goals and tasks in accordance with quality and corporate objectives. - Fluent in English (written and spoken). - Demonstrated written communication skills, as well as experience with presenting to leadership teams. - Business fluency and awareness - Advanced user-level of MS Office applications. - Experience of using QTS-Trackwise or SAP, an advantage. PHYSICAL POSITION REQUIREMENTS - This is full time position based at the Union City, California Site. 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 QA Operations Sr. Manager, Executive , Union City, California

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