Advisor-Quality Assurance, R&D Technical Development

Overview

In this role you will provide strategic quality leadership across global R&D, drive GMP/compliance excellence, and partner with cross-functional teams to align with Elanco standards and regulatory requirements. You will lead quality systems, training, and digital tools to support development, transfers, and launches. You’ll prepare for inspections and oversee third-party quality arrangements to ensure robust product quality. This is a chance to shape quality strategy in a world‑class animal health company and contribute to safer, compliant products.

Responsibilities

• Serve as global quality expert for R&D and project teams, setting quality strategies and delivering compliance training
• Oversee digital systems and equipment validation, including CSV, AI governance, ELN, and IQ/OQ/PQ processes
• Review CMC, preclinical, and clinical documentation; manage material release and inspection readiness
• Manage qualifications, audits, CAPA reviews, and Quality Agreements with CMOs, CROs, and TPOs
• Champion global R&D Quality Plans, self-inspections, quality metrics, and adherence to Elanco standards

Key requirements

• PhD in Life Sciences or Master’s degree with relevant equivalent experience in Pharmacy, Biology, Biotechnology, or Chemistry
• 5+ years’ experience in Quality Assurance, Quality Control, or related scientific field
• Expert knowledge of GMP and global regulatory requirements (FDA/CVM, EMA, MHRA/VMD), CMC activities, and R&D QA from development through registration
• Proven ability to interpret complex regulations, influence without authority, and drive quality outcomes across multidisciplinary teams

• cross-functional collaboration
• influencing without authority
• strong communication and training delivery
• GMP and global regulatory compliance
• CMC knowledge and R&D quality assurance from development to registration
• Computer System Validation (CSV)

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