ROLE OVERVIEW:
An exciting opportunity for a Qualified Person (QP) to join a leading biopharmaceutical manufacturer based in the Oxfordshire area. As the Qualified Person (QP), you will play a key role in batch certification and leading organisational and operational quality activities. You will be part of the senior leadership team within Quality Assurance, ensuring GMP compliance, driving quality strategy, and supporting regulatory engagement across the business.
KEY DUTIES AND RESPONSIBILITIES:
* Your duties as the Qualified Person (QP) will be varied however the key duties and responsibilities are as follows: Certifying Investigative Medicinal Products (IMPs) and/or commercial APIs in accordance with GMP and relevant regulations.
* Participating in the QA Leadership / Steering Team to input on quality strategy, objectives, and policies.
* Serving as EU Qualified Person (QP) for batch certifications in line with 2001/83/EC, Regulation 536/2014, and SI2012-1916.
* Hosting and supporting regulatory inspections, audits, and client/partner visits, ensuring QMS compliance and operational excellence.
* Overseeing review and approval processes for records, deviations, environmental monitoring, OOS/OOT results, and related documentation.
ROLE REQUIREMENTS:
* To be successful in your application to this exciting role as the Qualified Person (QP) we are looking to identify the following on your profile and past history:A Degree or higher level in Life Sciences or related discipline (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
* Extensive knowledge of GMP guidelines, Annex 1 EudraLex Volume 4, and regulatory requirements for IMP and commercial API manufacture.
* Proven experience in biologics, sterile manufacturing, and QMS oversight, including audits and regulatory inspections.
* Strong understanding of EU and UK regulations, clinical trial requirements, and validation systems.
* Familiarity with contract manufacturing models, stakeholder management, and external partner collaboration.
WHAT’S IN IT FOR YOU?
* Highly competitive total reward packages
* Wellbeing programmes
* Development opportunities
* A diverse and inclusive working environment
* Supportive colleagues and collaborative culture
* State-of-the-art laboratory and manufacturing facilities
* Key leadership role within the senior site team