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 methodologiesAuditing experienceAdditional Information:
Expected travel: up to 10%Onsite Hybrid - Speke, UKElanco 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
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