About this role
Job title: Quality Control Manager
About the Role The Quality Control Manager at Zoetis USA (Charles City) oversees biological QC operations to ensure vaccines meet US, EU and international regulatory requirements. Advises management on products not meeting testing specifications and recommends regulatory actions when products do not meet Zoetis or government requirements.
What You'll Do
- Oversee day-to-day activities in the Quality Control laboratories and Animal Test facility; manages four departments: Virology; Bacteriology and Immunology; Chemistry, Microbiology and Environmental Monitoring; and Animal Test.
- Ensure testing and release of all biological products per 9CFR, applicable cGMP regulations (EU, JP, etc.), and destination country requirements (US, EU, etc.).
- Responsible for APHIS sampling, APHIS Form 2008 preparation, Stability and Confirmation of Expiry Testing and submissions, LIMS management, and test sample distribution.
- Training and Development: Ensure all colleagues are adequately trained on cGMPs, safety, OSHA, technical skills, policies, and procedures; maintain accurate training documentation.
- Performance: Provide situational leadership, encourage teamwork, develop people, conduct performance appraisals; promote an inclusive environment and mutual accountability.
- Lead the Quality Operations (QO) QC unit; direct review and QC approval for test records, batch records, process worksheets, SOPs; ensure documentation aligns with Outlines of Production; review validation protocols and task reports.
- Coordinate with QC Laboratory personnel, Manufacturing and Planning to prioritize schedules for timely testing and release of products (saleable, experimental, stability, transfer).
- Work with Biological Manufacturing management to investigate and resolve quality/compliance issues via appropriate testing; participate in regulatory inspections; ensure ongoing compliance at Charles City; advise management on regulatory deficiencies and actions; engage in regulatory self-inspections.
- Manage systems supporting raw material release, final product release, new product transfers/specifications, APRs, stability, and complaints; establish audit readiness for testing documentation; implement robust communication networks across plant sites, senior management, and regulatory agencies.
- Ensure regulatory filings align with testing practices; actively support location and site leadership initiatives; promote colleague engagement and act as a change agent; monitor external regulatory changes.
What We're Looking For
- Education and Experience: BS/BA in a science-related field with 9-13 years of experience OR MBA/MS in science-related field with 7-11 years of experience.
- Technical Requirements: Proficient in Microsoft Word, Excel, and PowerPoint; ability to leverage advanced features for data analysis, reporting, and presentation development.
- Strong written and oral communication skills; familiarity with statistical analysis; strong problem-solving skills; strong technical writing skills.
- Knowledge of USDA, EU, and Animal Welfare Act guidelines.
Nice to Have
- Experience with LIMS management and test sample distribution.
- Experience participating in regulatory inspections and regulatory compliance self-inspection programs.
Compensation & Benefits
- Salary information and benefits not disclosed in the posting.