QA & Regulatory Lead, Biopharma/Vaccine Development

Zoetis, Inc; Lincoln (NE); On-site; USD 110,000 - 160,000; Full time

Job summary

Zoetis, Inc. is seeking a quality assurance and compliance expert for Veterinary Medicine Research & Development (VMRD).

The role covers the design, execution, and transfer of new biological/biopharmaceutical products to achieve department and site objectives. Responsibilities include ensuring facilities and product transfers comply with USDA, EU, FDA and Zoetis standards, supporting regulatory issues, and providing QA resources to development teams.

Qualifications

• Experience with QA auditing, cGMP and quality systems.
• Understanding of aseptic practices and regulatory frameworks (US/EU).
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Ensure compliance of VMRD facilities with USDA, EU, FDA and Zoetis standards.
• Provide QA consultation for development, clinical and VICH batches/serials.
• Review and approve validation protocols and reports.

Skills

QA auditing

cGMP

Aseptic practices

Regulatory knowledge

RFT and Lean

Communication skills

Interpersonal skills

Organizational skills

Adaptability

Education

Bachelor's degree in biological/pharmaceutical sciences or related

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

Job description

Zoetis, Inc. is seeking a quality assurance and compliance expert for Veterinary Medicine Research & Development (VMRD).

The role covers the design, execution, and transfer of new biological/biopharmaceutical products to achieve department and site objectives. Responsibilities include ensuring facilities and product transfers comply with USDA, EU, FDA and Zoetis standards, supporting regulatory issues, and providing QA resources to development teams.