R&D Quality & Compliance Advisor (GxP)

Elanco; Village of Liverpool (NY); Hybrid; USD 145,000 - 212,000; Full time

Job summary

Elanco seeks a strategic Advisor, Quality - R&D to provide global quality leadership and GMP compliance guidance across R&D teams, project groups, and CMOs to support product development, transfers, registrations, and launches.

You will drive continuous compliance by implementing quality systems, tools, and training tailored to development activities, ensuring alignment with Elanco standards and regulatory requirements.

Qualifications

• PhD in Life Sciences or MS with relevant equivalent experience.
• 5+ years in QA/QC or related technical field in pharma.
• Expert knowledge of GMP and global regulatory requirements.
• Ability to interpret regulations and drive quality across teams.

Responsibilities

• Provide Global Quality Leadership across R&D and project teams.
• Oversee CSV, AI governance, ELN implementation, and equipment commissioning.
• Lead material release and inspection readiness for regulators.
• Manage qualifications, audits, CAPA reviews, and Quality Agreements with CMOs/CROs.
• Champion Quality Plans, self-inspections, metrics and ethics standards.

Skills

Quality Assurance

Quality Control

GMP

Education

PhD in Life Sciences

Master’s degree in Life Sciences

Tools

CSV validation

ELN implementation

Job description

Elanco seeks a strategic Advisor, Quality - R&D to provide global quality leadership and GMP compliance guidance across R&D teams, project groups, and CMOs to support product development, transfers, registrations, and launches.

You will drive continuous compliance by implementing quality systems, tools, and training tailored to development activities, ensuring alignment with Elanco standards and regulatory requirements.