Site Quality Assurance Manager

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 regulations. 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. He/she will serve as a strategic partner alongside other business stakeholders to enable site objectives by meeting quality objectives.

JOB RESPONSIBILITIES:

• 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 Corrective 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.
• Ensure 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 organization's strategic plan.

EDUCATION AND EXPERIENCE:

• Undergraduate degree in pharmaceutical, biological, chemical sciences, or engineering.
• Relevant advanced degree preferred.
• Supervisory experience - 3 or more years
• QP Eligibility advantageous.
• Minimum of 8 years progressive experience in the quality assurance, quality control, manufacturing function, or release roles supporting commercial registered product operations for animal health or human health products.
• Detailed knowledge of cGMP's and demonstrated leadership of Regulatory Inspection Management and Regulatory Affairs.
• Knowledge / Expertise in Pharmaceutical Manufacturing Processes.
• Lean Six Sigma Qualification (Green Belt or Black belt) desirable.
• Success in maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles.

TECHNICAL SKILLS REQUIREMENTS:

• 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.

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).

Full timeRegularColleague

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