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 Engineering 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 Quality Engineering 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 Quality Engineering 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 Quality Engineering 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 the development of Quality goals and targets as part of the organization's 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).
RESOURCES MANAGED:
Leadership Development / Coaching of Staff; Quality Specialists, Quality Engineers and the PSG (Triage) Manager and team.
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
Minimum of 8 years progressive experience in the quality control, quality assurance, manufacturing function, quality engineering, or release roles supporting commercial registered product operations for animal health or human health medical devices and in vitro diagnostic products.
Detailed knowledge of cGMP's and demonstrated leadership of Regulatory Inspection Management and Regulatory Compliance
Knowledge / Expertise in Medical Device and In-Vitro Diagnostic Manufacturing.
Lean Six Sigma Qualification (Green Belt or Black belt) desirable.
Quality certifications (i.e., CQE) desirable
Success in maintaining Quality Systems and Standards at manufacturing site level in accordance with 21 CFR Part 820, ISO 13485, ISO 14971, ISO 9001, and IVDR 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 ETS-Trackwise or SAP, an advantage.
PHYSICAL REQUIREMENTS:
This is a Union City, California site based position.
This position will require fluent use of IT tools, teleconferencing, MS office tools, as well as SharePoint technologies, to share and manage information with Global QC Network and Quality Organization
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in [ California ] Base pay may vary based on location and other factors.
Base Pay Range: $130,000 - $200,000
This position is eligible for short-term incentive compensation. The position is also eligible for long-term incentive.
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time
Regular
Colleague
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