Sr. Manager, Quality Engineering

This position reports directly to the Site Quality Lead and will serve as Quality Engineering Manager overseeing quality engineering and lot release 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. The Quality Manager will act as a Business Partner at all times, ensure all Site Quality Objectives are met, and that the Site remains in a state of compliance with all applicable regulations.

Key processes that the QA Manager has ownership of includes materials controls, 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 and Quality Engineers 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.

The QA Manager will serve as a strategic partner alongside other business stakeholders to enable site objectives by meeting quality objectives.

POSITION RESPONSIBILITIES:

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 regulations. Responsible for preparation and maintenance of the site Validation Master Plan in line with current requirements.
• 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 Corrective and Preventative Action (CAPA) Triage meetings, when necessary.
• 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.
• Participate in inspection readiness and preparation activities, including front room and backroom support during regulatory site inspections.
• 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 Budgets and resource planning for roll up to the Site Quality Budget.
• Support t