R&D Quality Leader — GMP & Compliance

Elanco; Liverpool; Hybrid; GBP 70,000 - 105,000; Full time

Job summary

Elanco is seeking an Advisor, Quality – R&D to provide strategic quality leadership across global R&D teams, ensuring GMP compliance for product development, transfers, registrations, and launches. The role partners across functions to shape quality strategy and optimize systems, training, and processes.

The role focuses on CSV, ELN, IQ/OQ/PQ, and regulatory readiness, driving continuous improvement and ensuring inspections readiness with CMOs, CROs, and external partners.

Qualifications

• Ph.D. in Life Sciences or Master’s with relevant equivalent experience in a technical area.
• At least 5 years in Quality Assurance, Quality Control or related technical field (Pharmaceutical Development, Manufacturing, Chemical Engineering, etc).
• Expert knowledge of GMP and global regulatory requirements (FDA/CVM, EMA, MHRA/VMD) across CMC and R&D QA from development through registration.
• Proven ability to interpret complex regulations, influence without authority, and drive favorable quality outcomes across multi-disciplinary project teams.

Responsibilities

• Global quality leadership for R&D and project teams, setting quality strategies and coordinating training.
• Oversees CSV, AI governance, ELN, and equipment qualification to meet GxP standards.
• Reviews CMC, preclinical and clinical documentation; manages material release and prepares for regulatory inspections.
• Manages qualifications, audits, CAPA reviews, and Quality Agreements with CMOs, CROs, and external partners.
• Drives continuous improvement with global quality plans, self-inspections, metrics, and ethics standards.

Skills

Quality Assurance

Quality Control

Regulatory knowledge

Project leadership

GxP experience

Education

Ph.D. or Master’s in Life Sciences or related field

Tools

CSV (Computer System Validation)

ELN

IQ/OQ/PQ

Quality Systems

Job description

Elanco is seeking an Advisor, Quality – R&D to provide strategic quality leadership across global R&D teams, ensuring GMP compliance for product development, transfers, registrations, and launches. The role partners across functions to shape quality strategy and optimize systems, training, and processes.

The role focuses on CSV, ELN, IQ/OQ/PQ, and regulatory readiness, driving continuous improvement and ensuring inspections readiness with CMOs, CROs, and external partners.