Senior QA Scientist - Biopharma Product Development

Zoetis Inc; Oklahoma; Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

Zoetis Inc. seeks a seasoned QA/Regulatory professional to provide quality assurance and compliance expertise for Veterinary Medicine Research & Development. You will oversee transfers of new products to meet global standards and coordinate regulatory issues across functions.

Responsibilities include reviewing validation, manufacturing and analytical documentation, authoring risk assessments, and driving CAPAs. Strong expertise in cGMP and regulatory requirements is essential.

Qualifikationen

• Bachelor’s degree with 10 years of relevant experience, or a master's degree with 8 years of relevant experience, or equivalent combination of education and experience in biological or pharmaceutical sciences, engineering, or a 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 industry.
• Experience with QA auditing, cGMP, and quality systems.
• Knowledge of U.S. and EU regulations governing biological products.

Aufgaben

• Provide QA and compliance expertise for VMRD, ensuring transfer of products to meet objectives.
• Ensure facilities and transfers comply with USDA, EU, FDA and Zoetis standards and regulatory requirements.
• Collaborate on scale‑up, transfers, and regulatory issues with DST colleagues.
• Serve as QA consultant for development, clinical, and VICH batches/serials.
• Review master batch records, manufacturing and analytical documents for compliance and obtain QA approval.
• Review and approve validation protocols and reports.
• Prepare and review Outlines of Production/submissions with VMRD, VMRA and GMS.
• Lead deviation investigations related to manufacturing, packaging, testing and GMP functions.
• Provide guidance on CAPAs and effectiveness checks; identify root causes.

Kenntnisse

QA auditing

cGMP

Regulatory affairs

Analytical thinking

Communication

Lean principles

Right First Time

Aseptic practices

Interpersonal skills

Organizational skills

Adaptability

Ausbildung

Bachelor's degree + 10 years relevant experience

Master's degree + 8 years relevant experience

Equivalent combination of education/experience

Jobbeschreibung

Zoetis Inc. seeks a seasoned QA/Regulatory professional to provide quality assurance and compliance expertise for Veterinary Medicine Research & Development. You will oversee transfers of new products to meet global standards and coordinate regulatory issues across functions.

Responsibilities include reviewing validation, manufacturing and analytical documentation, authoring risk assessments, and driving CAPAs. Strong expertise in cGMP and regulatory requirements is essential.