Site Quality Lead

Site Quality Lead

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.

Key responsibilities include :

• 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.

Position responsibilities :

Education and experience :

Technical skills and competencies :

Physical requirements :

The US base salary range for this full-time position is $170,000 - $260,000. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the base pay target range for new hire salaries for the position. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

This position is also eligible for short-term incentive compensation. This position is also eligible for long-term incentives. In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.