QA Scientist — Biopharma Product Development

Zoetis; Lincoln (NE); On-site; USD 110,000 - 150,000; Full time

Job summary

Zoetis is seeking a Quality Assurance & Compliance expert for Veterinary Medicine Research & Development (VMRD) to lead QA activities, ensure regulatory compliance, and support technical transfers of biopharmaceutical products. You will collaborate across development, manufacturing, and regulatory teams to maintain high quality standards and drive CAPAs.

The role requires deep knowledge of GMP, QA auditing, and regulatory frameworks, with a focus on vaccine/biopharmaceutical development and

Qualifications

• Minimum of 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs in veterinary or human pharma.
• Auditing experience and knowledge of cGMP regulations across US and international markets.
• Strong ability to review technical documentation and ensure regulatory preparedness.
• Effective cross-functional collaboration with development, regulatory, and manufacturing teams.
• Proactive in identifying CAPAs and driving corrective actions.

Responsibilities

• Ensure production facilities and transfer of products comply with USDA, EU, FDA, and Zoetis quality standards and destination country regulations.
• Serve as QA consultant for development, clinical, and VICH batches; provide regulatory documents and compliance resources.
• Review master batch records, manufacturing and analytical documents for accuracy and compliance; grant QA approval.
• Review validation protocols/reports and support Outlines of Production/submissions with teams.
• Conduct deviation investigations; propose root cause analysis and CAPAs with effectiveness checks.
• Approve changes to manufacturing processes, equipment, and IT systems; maintain GMP documents.
• Ensure supplier processes meet quality standards; author risk assessments within project teams.
• Maintain regulatory knowledge and advise on deficiencies with appropriate actions.
• Provide training and mentoring within teams; may supervise colleagues.

Skills

Quality Assurance

Regulatory Affairs

cGMP compliance

Auditing

Education

Bachelor's degree in biological or pharmaceutical sciences

Master's or PhD preferred

Tools

Quality Systems

Job description

Zoetis is seeking a Quality Assurance & Compliance expert for Veterinary Medicine Research & Development (VMRD) to lead QA activities, ensure regulatory compliance, and support technical transfers of biopharmaceutical products. You will collaborate across development, manufacturing, and regulatory teams to maintain high quality standards and drive CAPAs.

The role requires deep knowledge of GMP, QA auditing, and regulatory frameworks, with a focus on vaccine/biopharmaceutical development and