Director, Qualified Person (QP)

Job description:

We pride ourselves on our integrity. We do what’s right for our employees, patients, and partners, and so can you.

We are currently recruiting for a Qualified Person (QP) to join the Quality Assurance team. The purpose of this role is to perform batch certification and help direct organisational and operational quality activities.

Oxford Biomedica’s QA team is responsible for the company’s quality processes and systems, in compliance with GMP guidelines. The team handles internal and external audits, quality compliance, and control.

Your responsibilities in this role would include:

• Certifying that Investigative Medicinal Products (IMPs) and/or commercial APIs are manufactured in accordance with GMP.
• Participating in the QA Leadership / Steering Team.
• Contributing to quality policy, objectives, and deliverables.
• Making quality decisions and developing strategies that balance quality with business objectives.
• Participating in project, client, and partner meetings.
• Serving as a key QA contact for external parties.
• Serving as EU Qualified Person (QP) for batch certifications in accordance with relevant regulations.
• Overseeing BMRs and supporting record reviews and approvals (deviations, EM, analytical, OOS/OOT, etc.).
• Providing guidance on European, UK, and US regulations, as well as harmonized guidelines like PIC/S and ICH.
• Ensuring GMP knowledge is maintained within the team and across functions.
• Participating in self-inspections and external audits.
• Hosting and supporting regulatory inspections and audits by clients and partners.
• Maintaining QMS oversight as part of QP responsibilities.

Profile description:

We are looking for:

• A degree in Life Sciences or a postgraduate qualification.
• Knowledge and experience in biologics and sterile manufacture, preferably aseptic, with understanding of MHRA authorizations and Annex 1 EudraLex Volume 4.
• Expertise in GMP guidelines, validation, and quality management systems.
• Knowledge of clinical trials, IMP, and medicines regulatory systems.
• Commitment to ongoing professional development to maintain QP status.
• Understanding of articles 48-53 of Directive 2001/83/EU and related regulations.
• Extensive knowledge of quality management principles in a GxP environment, from early clinical to commercial stages.
• Experience working with customers and partners in a contract manufacturing setting.
• Proficiency with eQMS and MS Office applications.
• Proven experience hosting regulatory inspections as a Pharmaceutical Auditor.

About Us:

Oxford Biomedica is a pioneering viral vector CDMO focused on cell and gene therapy, with over 25 years of experience. We collaborate globally to develop and manufacture viral vectors like lentivirus, AAV, and adenoviral vectors, supporting projects from early development to commercialization, backed by robust quality systems and regulatory expertise.

What’s in it for you:

• Highly competitive reward packages
• Wellbeing programs
• Development opportunities
• Supportive colleagues
• Diverse, inclusive environment
• State-of-the-art facilities

We aim to inspire daily and succeed through passion, commitment, and teamwork. Join us to make a difference.