QA Leader – Biopharma Product Development & Compliance

Zoetis, Inc; Lincoln (NE); On-site; USD 120,000 - 170,000; Full time

Job summary

Zoetis, Inc. is seeking an experienced QA/Regulatory professional to ensure quality and compliance for Veterinary Medicine Research & Development.

The role covers design, transfer, and approval of biopharmaceutical products across facilities, with emphasis on regulatory alignment and process improvements. You will work with DST colleagues on scale-up, regulatory issues, and provide QA support for development and manufacturing activities.

Qualifications

• Bachelor's degree in biological or pharmaceutical sciences with 15 years of experience, or equivalent.
• Minimum of 5 years of progressive experience in QA, manufacturing, QC, or regulatory affairs in veterinary or human pharma/biologics.
• Experience with QA auditing, cGMP, and quality systems.
• Thorough knowledge of US/EU regulations governing biological products and their application.
• Strong written and verbal communication skills for internal and external stakeholders.

Responsibilities

• Ensure VMRD facilities and transfers comply with USDA, EU, FDA, Zoetis quality standards and destination country regulatory requirements.
• Serve as QA consultant for development, clinical, and VICH batches/serials and provide regulatory documents and quality resources.
• Review master batch records and manufacturing/analytical documents for accuracy and compliance, and provide QA approval.
• Review and approve validation protocols and reports; collaborate on Outlines of Production/submissions.
• Conduct and review deviation investigations, identify root causes, CAPAs, and effectiveness checks.
• Evaluate and approve changes to manufacturing/packaging equipment, processes, testing, and IT systems.
• Coordinate supplier audits and pre-approval surveys to ensure continued regulatory compliance.
• Participate in cross-functional teams to maintain Lincoln Operations compliance and continuous improvement.
• Advise management on regulatory deficiencies and appropriate actions.
• Maintain current knowledge in vaccine/biopharmaceutical development.
• Mentor/coach team members and potentially supervise colleagues.

Skills

Quality Assurance

Regulatory Affairs

cGMP

Aseptic Practices

Documentation

Team Collaboration

Decision Making

Analytical Skills

Education

Bachelor's degree in biological or pharmaceutical sciences

15 years of experience or equivalent

Master's or PhD in biological science/chemical engineering

Tools

QA auditing tools

Job description

Zoetis, Inc. is seeking an experienced QA/Regulatory professional to ensure quality and compliance for Veterinary Medicine Research & Development.

The role covers design, transfer, and approval of biopharmaceutical products across facilities, with emphasis on regulatory alignment and process improvements. You will work with DST colleagues on scale-up, regulatory issues, and provide QA support for development and manufacturing activities.