Quality Control Manager

Position Summary

Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advises Management of products not meeting required testing specifications and recommends appropriate regulatory actions when products do not meet Zoetis or government requirements.

• Oversee day-to-day activities in the Quality Control laboratories and Animal Test facility.
• Manage four departments within the Quality Control Organization:
  Virology;
  Bacteriology and Immunology;
  Chemistry, Microbiology and Environmental Monitoring; and Animal Test.
• Assure overall quality and integrity of biological products manufactured and distributed worldwide based on 9
  
  CFR, applicable cGMP regulations (EU, JP, etc.), and industry standards.
• Ensure all biological products manufactured by or distributed by Charles City are tested according to applicable USDA, EU and Zoetis quality standards, as well as the regulatory requirements of a destination country.
• Responsible for APHIS sampling, APHIS Form 2008 preparation, stability and confirmation of expiry testing and submissions, LIMS management, and test sample distribution.
• Ensure all colleagues are adequately trained and continue to receive training on cGMPs, safety, OSHA, technical skills, policies, and procedures, and that training documentation is accurate.
• Use situational leadership skills; encourage full participation and teamwork; commit to developing people; conduct performance appraisals; create an inclusive environment and promote mutual accountability.
• Provide leadership for the QC Quality Control unit; direct the review and give QC approval for test records, batch records, process worksheets, Standard Methods, and SOPs; ensure testing and manufacturing documents follow the Outlines of Production; review and approve validation protocols and task reports, as necessary.
• Work with QC Laboratory personnel, Manufacturing and Planning to organize and prioritize schedules to ensure timely testing and release of all products.
• Investigate and resolve processing quality and compliance issues by ensuring appropriate and expedient testing.
• Actively participate in regulatory inspections of the Charles City facility.
• Manage systems that support raw material release, final product release, new product transfers/specifications, APRs, stability, and complaints.
• Establish systems to assure audit readiness of all testing documentation by regulatory agencies and internal auditors.
• Implement strong communication networks for information flow to and from plant sites, senior management, staff groups, and regulatory agencies.
• Ensure compliance between current testing practices and the regulatory filings through a Regulatory Compliance self‑inspection program.
• Actively engage to support location and site leadership initiatives; demonstrate a passion for colleague engagement and act as an active change agent.
• Monitor changes in the external regulatory community.

BS/BA in a science‑related field with 9–13 years of experience, OR MBA/MS in a science‑related field with 7–11 years of experience.

• Proficient in Microsoft Word, Excel, and PowerPoint, with the ability to leverage advanced features for data analysis, reporting, and presentation development.
• Strong written and oral communication skills.
• Familiarity with statistical analysis and strong problem‑solving skills.
• Strong technical writing skills.
• Knowledge of USDA, EU, and Animal Welfare Act guidelines.

Must be able to walk, sit, or stand for long periods; reach above shoulder level; bend/stoop, kneel, push/pull, and handle/grip frequently; perform 40‑hour scheduled work with overtime and weekend availability; lift and carry 5–25 lbs; repetitive motion and substantial movement of wrists, hands, and/or fingers; grasp and manipulate objects like pipettors, flasks, and bottles; flexibility to cover rotating weekend duties.

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color,…