Zoetis

Site Quality Lead

Union City, California, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Medical DevicesIndustries

Requirements

A Bachelor's degree in science, animal science, or veterinary fields is required, with advanced degrees (MS/PhD) in Science or Engineering being a plus. Candidates need 10-15 years of experience in Regulatory Affairs and/or Quality Assurance, preferably within an in vitro diagnostic production facility. Significant leadership experience in Quality roles within Animal Health, Human Health Medical Devices, or In Vitro Diagnostics is essential, along with a strong background in Operations or Quality within Medical Device and In Vitro Diagnostics.

Responsibilities

The Site Quality Lead is accountable for all site Quality functions, including QA, QC, Quality Operations, and Compliance, ensuring adherence to Zoetis and regulatory requirements. This role involves leading, planning, and delegating submissions and licensure for product line improvements, directing QA and QC departments, and serving as the Management Representative for the site. Responsibilities include championing a Quality Culture, maintaining the independence of the Quality unit, participating in the Site Leadership Team, establishing annual Quality Plans and SOPs, leading risk assessments, and utilizing data for continuous improvement. The role also includes directing Quality resources for product availability, maintaining the Supplier Quality program, ensuring validation plan compliance, developing metrics, leading leadership development for Site Quality staff, owning Site Product Portfolio Quality, participating in new product development, preparing and managing the department's annual budget (up to $2M), overseeing Regulatory, QA, QC, and Quality Operations functions, and managing a team of direct and indirect reports. The position requires daily interaction with plant personnel, collaboration with various Zoetis functions, interfacing with regulatory bodies, and co-leading Site Quality Councils.

Skills

Quality Assurance
Quality Control
Compliance
FDA regulations
ISO 13485
IVDR
Risk Assessment
Quality Management Systems
Leadership
Process Improvement
Auditing
Standard Operating Procedures (SOPs)

Zoetis

About Zoetis

N/AHeadquarters
N/AYear Founded
N/ACompany Stage

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