Site Quality Lead

Role Summary

The Site Quality Lead is accountable for all Quality functions at the site, including Quality Assurance, Quality Control, Quality Operations, and Compliance. This role achieves site and corporate quality objectives through effective leadership, development, and coaching of staff, ensuring robust systems and processes are in place to meet or exceed Zoetis and regulatory requirements. As the designated Management Representative per 21 CFR Part 820 and ISO 13485, the Site Quality Lead ensures the facility's compliance with FDA regulations, ISO guidelines, IVDR, and other applicable standards.

Responsibilities

• Leading, planning, and delegating submissions and licensure for product line improvements.
• Ensuring product quality and site compliance.
• Directing Quality Assurance and Quality Control departments to fulfill company and regulatory requirements.
• Serving as Management Representative for the site.
• Reporting issues that impact marketed products, including headcount and budget constraints, to the Quality Platform Leader.
• Championing the Quality Culture and proactively maintaining high standards of quality and compliance.
• Ensuring the site Quality Policy is understood, implemented, and maintained at all levels.
• Maintaining the independence and authority of the Quality unit and ensuring adequate, well-trained resources.
• Participating in the Site Leadership Team to set strategic direction for the quality unit and site, while managing day-to-day quality operations.
• Establishing and maintaining an annual site Quality Plan, Standard Operating Procedures, and Quality Audit plans.
• Leading the Site Risk Assessment Process with the Site Leadership Team.
• Utilizing data and metrics to drive continuous improvement in site quality systems and product quality.
• Creating and executing the Site Quality Roadmap.
• Direct Quality resources to ensure the continuous availability of quality products, coordinating with cross-functional teams.
• Maintain the Supplier Quality program and oversee vendor certification.
• Ensure the Validation Master Plan is compliant and up to date.
• Develop and track metrics for product and process improvement.
• Champion leadership development for Site Quality staff.
• Own overall stewardship and accountability for the Site Product Portfolio Quality.
• Participate in new product development, product improvement, cost reduction, and existing product maintenance.
• Prepare and manage the department's annual budget; make critical regulatory and quality decisions with upper management input as needed.
• Oversee Regulatory Functions (25%), QA Functions (25%), QC Functions (25%), and Quality Operations (25%).
• Manage a budget of up to $2M per year, plus personnel costs; ensure site compliance with FDA, local, state, federal, and international regulations to maintain product supply.
• Lead salaried managers in Quality Control, Quality Assurance, Quality Operations, and Compliance (4 direct reports, 65+ indirect reports).
• Interact daily with plant personnel across all disciplines.
• Collaborate routinely with Zoetis functions including Quality Operations, Regulatory Affairs, R&D, Sales, Procurement, EHS, HR, Global QSS, Corporate Quality Auditing, and Operational Excellence.
• Interface with FDA and regulatory bodies as needed.
• Co-lead Site Quality Councils and metrics reporting.

Qualifications

• 10-15 years of experience in Regulatory Affairs and/or Quality Assurance, ideally within an in vitro diagnostic production facility.
• Post-graduate coursework focused on Regulatory Affairs or Quality Assurance is beneficial.
• Significant leadership experience in Quality roles within Animal Health, Human Health Medical Devices, or In Vitro Diagnostics.
• Strong background in Operations or Quality within Medical Device and In Vitro Diagnostics environments.
• Experience working in FDA and EU regulated environments is desired.
• Proficiency in Six Sigma and/or Lean Manufacturing methodologies.
• Extensive knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 standards.

Education

• Bachelor's degree required; emphasis in science, animal science, or veterinary fields preferred. Advanced degrees (MS/PhD) in Science or Engineering are a plus.

Skills

• Ability to effectively use and review application of scientific methods required.
• Ability to effectively review validation proposals and reports for adequate technical justification of conclusions.
• Ability to effectively review in-process and product final testing to insure compliance with requirements.
• Ability to effectively identify additional testing requirements and analyze results when product testing does not fall within required limits or when other information calls in to question a products adequacy for use.
• Ability to identify testing requirements for new and or improved products with the aid of VMRD colleagues.
• Ability to effectively organize process audits to insure a high level of compliance.
• Strong computer skills including Outlook, PowerPoint, Excel, Word.
• SAP, Veeva Vault, and ETS experience a plus. Previous LIMS implementation a plus

Additional Requirements

• While performing the duties of this job, incumbent must be able to access all areas of the facility, and utilize certain Personal Protective Equipment including, but not limited to, hard hats, safety shoes, eye protection, gloves, and/or protective clothing.
• Job will entail occasional lifting of up to 30 pounds; frequent bending, walking and stopping within a manufacturing environment; significant computer usage.
• Travel is required including International travel, typically less than 5% overall, but at times may exceed including weekend stays.