Quality Assurance Operations 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.This position reports directly to the Site Head of Quality 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 manufacturing and packaging 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: executed batch record review, validation master plans (VMP) and deviation/event/CAPA. 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 individual”s 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. They will serve as a strategic partner alongside other business stakeholders to enable site objectives by meeting quality objectives.
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 responsibilities of this position include: Provision of QA oversight and support for Operations in the following key area/activities: manufacturing across all phases of development and commercial manufacture, 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 regulations. Responsible for scheduling and tracking Batch Release activities, including review of executed batch record for manufacturing and packaging operations. 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 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 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. Write, Review and/or Approve GMP procedures related to material storage, dispensing, manufacturing and packaging within Operations. Identify and communicate potential compliance gaps / risks to management. Providing 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 a QA contact on New Product Risk Assessment, including alignment with established procedures for prevention of cross contamination during product new transfer activities 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 organisation”s strategic plan