Advisor-Quality Assurance, R&D Technical Development

• Education: Ph. D. in Life Sciences or Master’s degree with relevant equivalent experience in Technical Area (Pharmacy, Biology, Biotechnology, Chemistry)
• 5+ years’ experience in Quality Assurance, Quality Control or related technical field (Pharmaceutical Development, Manufacturing, Chemical Engineering etc.)
• Expert knowledge of GMP and global regulatory requirements (e.g., FDA/CVM, EMA, MHRA/VMD), CMC-related activities, and R&D Quality Assurance from development through registration.
• Proven ability to interpret complex regulations/policies, influence without authority, and drive favorable quality outcomes across multi-disciplinary project teams.

• Vaccine / animal health and/or biotherapeutics (large molecule) development background.

• Experience in equipment qualification (plans, test scripts, summary reports) and computerized system validation (CSV) with IT/Engineering.

• Experience designing or maintaining R&D Quality Systems, standard processes, and compliance training programs.

• Skilled in Quality risk-assessment methodologies

• Auditing experience

Provides Quality Leadership and GMP compliance guidance across global R&D teams, project groups, and CMOs to support product development, technical transfers, registrations, and successful launches. Partners cross-functionally to shape overall quality strategy and ensure full alignment with Elanco standards and global regulatory requirements. Proactively drives continuous compliance by implementing and optimizing quality systems, tools, and training tailored to technical development activities. 

• →Strategic Quality Leadership & Project Guidance: Serves as a global quality expert across R&D and project teams, setting quality strategies, resolving complex compliance challenges, and developing and delivering compliance training.
• →Digital Systems & Equipment Oversight: Drives quality oversight for Computer System Validation (CSV), AI governance, ELN implementation, and equipment commissioning (IQ/OQ/PQ) to ensure digital tools and systems meet GxP and regulatory standards.
• →GxP Documentation, Release & Inspections: Conducts scientific and compliance reviews of CMC, preclinical, and clinical documentation, oversees material release (drug substance/product), and leads inspection readiness for regulatory authorities.
• →Third-Party & Vendor Oversight: Manages qualifications, audits, CAPA reviews, and Quality Agreements for external partners including CMOs, CROs, and TPOs.
• →Quality Excellence & Continuous Improvement: Champions global R&D Quality Plans, self-inspections, quality metrics, and adherence to all Elanco Global Quality, HSE, and ethics standards.

• Expected travel: up to 10%
• Onsite Hybrid - Speke, UK

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