Qualified Person
ReplimuneVale of White Horse, England, United Kingdom
Posted November 6, 2025
Full Time
About the Company
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.
Job Description
The Qualified Person (QP) must ensure that each individual batch of product has been manufactured and checked in compliance with laws in force in the UK or EU Member State where certification takes place, as applicable, in accordance with the requirements of Good Manufacturing Practice (GMP) and in compliance with the relevant marketing authorisation or clinical trial authorisation and product specification file, including clinical trial protocol, for a given product and associated trial.
Requirements
- B.A or B.S. degree in an appropriate scientific field, M.S., Ph.D. or other postgraduate degree encouraged
- Eligible as Qualified Person satisfying the provisions of Article 49 of 2001/83/EC
- Maintain up to date regulatory and industry knowledge through program of Continuous Professional Development
- Knowledge of EU and UK regulations and guidelines regarding GMPs
- Sufficient industry experience no less than two (2) years of experience within relevant pharmaceutical fields
- Experience with steriles required and Advanced Therapy Medicinal Products (ATMP) preferred
Benefits
- Competitive and forward-looking total rewards program
- Innovative and collaborative culture
