Senior Quality Assurance & Regulatory Lead – Biopharma

Zoetis Inc; Oklahoma; On-site; USD 120,000 - 180,000; Full time

Job summary

Zoetis Inc. is seeking a senior QA/Compliance professional for Veterinary Medicine Research & Development (VMRD) in the United States.

The role focuses on ensuring quality, regulatory compliance, and successful technology transfers of biopharmaceutical products. You will work with Development Science & Technology and cross-functional teams to maintain high regulatory standards, review critical documents, and drive CAPA processes while mentoring colleagues.

Qualifications

• Bachelor's degree with 15 years' experience, or equivalent, in biological/pharmaceutical sciences or related discipline.
• Minimum of 5 years of progressive experience in Quality Assurance, Manufacturing, Quality Control, or Regulatory Affairs within veterinary or human pharmaceutical/biological products.
• Experience with quality audits, cGMP, and quality systems; regulatory knowledge of US/EU requirements.

Responsibilities

• Provide QA and compliance expertise for VMdR progrms, including design, execution, and transfer of products.
• Ensure facilities and transfers comply with USDA, EU, FDA, and Zoetis quality standards and regulatory requirements.
• Review master batch records, manufacturing and analytical documents for accuracy and compliance; approve validation protocols/reports.
• Assist with regulatory documents, CAPAs, and supplier QA activities; support cross-functional teams on scale-up and technology transfers.
• Provide guidance on deviations, investigations, and CAPAs; mentor and lead in a team setting.

Skills

QA auditing

cGMP compliance

Quality systems

Regulatory knowledge (US/EU)

Right First Time (RFT)

Lean principles

Oral and written communication

Analytical skills

Problem solving

Education

Bachelor's degree in biological/pharmaceutical sciences or related discipline

Master's or PhD in biological science or chemical/bioprocess engineering (preferred)

Job description

Zoetis Inc. is seeking a senior QA/Compliance professional for Veterinary Medicine Research & Development (VMRD) in the United States.

The role focuses on ensuring quality, regulatory compliance, and successful technology transfers of biopharmaceutical products. You will work with Development Science & Technology and cross-functional teams to maintain high regulatory standards, review critical documents, and drive CAPA processes while mentoring colleagues.