Product Development Quality Assurance Senior Associate

Role Summary

The Product Development QA Sr. Associate provides quality assurance oversight for biological starting materials (Master Seed/Cell Banks) and raw materials for immunological and biopharmaceutical products used in the research and development of veterinary medicinal products. The role is compliance focused and is responsible for reviewing and approving documents related to raw material selection, production, and testing. Additional responsibilities include generating certificates of analysis and TSE/BSE compliance statements for both internal and external use. The Sr. Associate partners closely across R&D, Master Seed/Master Cell (MS/MC) Manufacturing, Supply Chain, and Regulatory Affairs teams, and is responsible for ensuring compliance with internal quality standards and regulatory guidelines, including those from the USDA Center for Veterinary Biologics (CVB), FDA Center for Veterinary Medicine (CVM), and EMA Committee for Medicinal Products for Veterinary Use (CVMP).

Responsibilities

• Master Seed/Cell Bank Quality Oversight
  • Oversee the establishment, characterization, and maintenance of MS/MC banks in compliance with internal and regulatory standards.
  • Review and approve production records, testing records, stability reports, and requalification documentation to ensure accuracy, completeness, and compliance with regulatory and internal requirements.
  • Ensure traceability and documentation of all Master Seed/Cell banks.
• Quality Systems & Compliance
  • Review and approve SOPs, protocols, risk assessments and other process documents related to biological bank activities and material selection.
  • Partner closely with Global and Site-based Manufacturing Quality Assurance to align with on-site operational requirements and best practices.
  • Conduct internal compliance audits of MS/MC processes, ensuring alignment with internal procedures, quality standards and regulatory requirements.
  • Investigate deviations, non-conformances, and implement effective CAPA associated with master seed / cell production and raw material selection.
  • Support internal, external, and regulatory inspections acting as subject matter expert for MS/MC banks and associated raw materials.
  • Utilize Global Quality Systems, as needed, including SAP, ETS and Veeva Vault.
• Cross-functional Collaboration
  • Work with R&D, MS/MC Manufacturing, Regulatory Affairs, and Supply Chain to ensure compliance during development and production of MS/MC banks.
  • Provide QA guidance during development and scale-up of new MS/MC banks and processes.
  • Participate in staff and project meetings, document reviews, and consultations with VMRD colleagues.
• Continuous Improvement
  • Identify and support improvements in QA processes, documentation practices, and material selection.
  • Monitor regulatory trends and update practices to maintain compliance.
  • May assume a lead role for various QA projects within the PSQL group and/or VMRD.
• Raw Material Support
  • Support the identification, selection, and risk evaluation of raw materials and critical reagents used during research and development.
  • Assist in developing specifications, risk assessments, and control strategies for raw materials, ensuring alignment with relevant regulatory expectations.
  • Support review of supplier documentation, certificates of analysis, and change notifications.

Qualifications

• Required: Bachelor's or Master's degree in Biology, Microbiology, Biotechnology, Chemistry, Animal Science, or related field.
• Required: 3+ years of experience in Quality Assurance within the pharmaceutical, biotechnology, or animal health industry, with experience in product development, biological bank oversight, and/or raw material selection.
• Required: Working knowledge of GMP, GLP, and relevant regulatory requirements (e.g., USDA, FDA, EMA).
• Required: Experience utilizing enterprise systems (e.g., SAP, ETS, Veeva Vault) to support documentation, traceability, and process management activities.
• Preferred: Experience with veterinary biologics or vaccines.
• Preferred: Familiarity with cell culture, fermentation, or seed / cell bank processes.
• Preferred: Experience leading QA projects or compliance initiatives.
• Preferred: Demonstrated ability to work independently and in cross-functional teams.
• Preferred: Demonstrated ability to travel as needed (5-15%).
• Preferred: Experience supporting regulatory submissions, inspections, or compliance activities is highly desirable.
• Preferred: Strong documentation, organizational, and communication skills.
• Preferred: Demonstrated proficiency for documentation review with a strong attention to detail.

Additional Requirements

• Travel as needed (5-15%).