Advisor-Quality Assurance, R&D Technical Development

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

At Elanco (NYSE: ELAN) - it all starts with animals!

As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.

At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.

Making animals' lives better makes life better - join our team today!

Your Role: Advisor, Quality - R&D

Position Description:

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.

Your Responsibilities:

• 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.

What You Need to Succeed (Minimum Qualifications):

• 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.

What Will Give You a Competitive Edge (Preferred Qualifications)

• 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

Additional Information:

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

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job-related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.