This position reports to the Site Quality Lead, and will serve as the most senior Quality Control Leader for the Site. The Site Quality Control Lead will have overall responsibility to manage and control all QC activities in accordance with identified Global Zoetis Quality Systems and Standards as well as all relevant regulatory and legislative regulations across the lifecycle of the Site products.
Direct and oversee analytical activities by providing a Fit for Purpose and Safe working environment in which all equipment and methods are in a validated state and compliant with applicable regulations. Management of the Lab operations includes: Testing Management of all Site Materials; Raw Materials, Inprocess and Finished Product Samples; Stability Testing; House Retains; Environmental Monitoring; Utilities; and Microbial testing. Lab management also includes maintenance of laboratory materials necessary to perform testing, maintaining laboratory data integrity, and overseeing laboratory investigations.
Develop, Maintain, and Communicate Analytical Services Key Performance Metrics. Continuous Improvement is facilitated by use of metrics and process mapping to identify initiatives to enhance Lab performance. Ensure that the Analytical group operates in a cost effective and efficient manner and maintain an innovative approach based on productivity improvement and implementation of best practices. The Manager will also keep succession plans up to date as well as oversee the groups’ training plans and training completion.
As a member of the Site Quality Lead Team – assist in Strategy Development and stewardship of the Site Quality Culture.
Key objectives of this position include:
- Manage the day to day operations of the Quality Control laboratory including but not limited to: providing a safe, secure and efficient working environment; ensure all QC equipment is validated and safely operated; all physical QC assets are maintained, stored and organised to allow efficient and effective operation;
- Maintain the Lab in a state of Fit for Purpose that includes both Regulatory Compliance as well as functionality (equipment calibration & qualification, equipment maintenance, QC IT tool & automation system validation)
- Reinforce Data Integrity knowledge, training, and actions.
- Oversee Key Lab functions that include: Testing Management of all site materials; samples; Stability Testing; House Retains; Environmental Monitoring; Utilities; and Microbial testing.
- Develop; Maintain; and Communicate Lab Key Performance Metrics (KPIs)
- Establish and maintain the Lab Capacity Utilization model and identify areas for continuous improvement to improve productivity.
- Immediate notification to the Site Quality Lead of any Quality Control issues, and provide accurate and relevant information as required by the business.
- Oversee and direct the analytical method transfer for Site products (transfers in and out)
- Ensure that analytical methods are adequately developed, validated, transferred and maintained
- Approve documents related to analytical methods development & validations
- Maintain analytical method validation plans
- Ensure that adequate and timely analytical support for investigations (e.g. non-conformances complaints) and troubleshooting is provided, where needed in conjunction with GMT, Opex, external 3rd party laboratories, and other involved Zoetis functions to minimize impact on product availability and sales. Report all OOS/OOT/OOE for timely investigation
- As Applicable - ensure the adequate and timely qualification of contract laboratories using appropriate quality management tools to monitor and ensure third party lab compliance with Zoetis Quality Policies and applicable regulatory requirements on an ongoing basis e.g. QA Agreements, audits with appropriate follow up, risk assessments, Product Optimization action plans, performance indicators, follow up stability and product quality review.
- Assist the Site Quality department, as the main auditee for the Quality Control Laboratory, with preparation, management and follow up of internal audits and Health Authority inspections, as needed
- Review and monitor action plans for correction of audit observations related to the Analytical Labs and follow-up as appropriate.
- Support the development of quality goals and targets as part of the organisation’s strategic plan
- Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean Lab methodology.
Staff and Leadership Responsibilities
- Leadership Development / Coaching of Staff; Creation of Learning Organization
- Stewardship of the Quality Culture within the QC Function as well as the Site.
- Insure Training and Development plans are in place for all QC associates.
- Development of Site QC 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.
This position will need to achieve results through colleagues with a direct reporting relationship (Site QC team) as well as indirectly. The successful candidate will need to interact regularly with leadership at the site, GMT, regulatory affairs, to assure quality goals and objectives are met.
EDUCATION AND EXPERIENCE
- Bachelor of Science in Chemistry with +10 years of quality control and analytical laboratory experience.
- Demonstrated experience in leading a QC team.
- Lean and/or Six Sigma fluency
TECHNICAL SKILLS and COMPETENCIES REQUIRED
- Minimum of 10 years supervisory/leadership experience.
- Project management competency.
- Demonstrated skills organizing and tracking data and documents.
- Demonstrated written communication skills, as well as experience with presenting to leadership teams.
- Must have strong technical/analytical skills
- Demonstrated ability to work with internal and external colleagues.
- Technical expertise/knowledge of Good Laboratory Practices, Data Integrity/Data Governance, and KPI’s
PHYSICAL POSITION REQUIREMENTS
- This is a Union City, California site based position
- This position will require fluent use of Lims and IT tools, teleconferencing and Webex tools, as well as Sharepoint technologies, to share and manage information with Global QC Network and Quality Organization