Director, Qualified Person (QP)

OXB; England; On-site; GBP 40,000 - 70,000; Full time

Job summary

A pioneering viral vector CDMO in the UK is seeking a Qualified Person (QP) for its Quality Assurance team. You will perform batch certifications and direct quality activities in compliance with GMP guidelines. Ideal candidates possess a degree in Life Sciences and experience in biologics or sterile manufacturing, coupled with a strong understanding of GMP and clinical regulatory systems. This role offers competitive rewards, developmental opportunities, and a diverse working environment.

Benefits

Highly competitive rewards

Wellbeing programs

Development opportunities

Supportive colleagues

Diverse, inclusive environment

State-of-the-art facilities

Qualifications

• Degree in Life Sciences or a postgraduate qualification required.
• Experience and knowledge in biologics and sterile manufacturing.
• Commitment to ongoing professional development to maintain QP status.

Responsibilities

• Certifying that Investigative Medicinal Products are manufactured in accordance with GMP.
• Participating in the QA Leadership/Steering Team.
• Serving as a key contact for external QA parties.

Skills

Experience in biologics

Knowledge of GMP guidelines

Expertise in Quality Management Systems

Understanding of clinical trials

Proficiency in eQMS

Education

Degree in Life Sciences or postgraduate qualification

Tools

MS Office applications

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 Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GMP guidelines. The team is accountable for internal and external audits, quality compliance, and control.

Your responsibilities would include:

• Certifying that Investigative Medicinal Products (IMPs) and/or commercial APIs are manufactured in accordance with Good Manufacturing Practice (GMP).
• Participating in the Quality Assurance (QA) Leadership/Steering Team.
• Contributing to quality policy, objectives, and deliverables for the business.
• Making quality decisions and developing go-forward strategies that balance quality with business objectives.
• Participating in project meetings, client, and partner meetings.
• Serving as a key contact for external QA parties.
• Acting as the EU Qualified Person (QP) for batch certifications according to 2001/83/EC, Regulation 536/2014, and SI2012-1916.
• Overseeing Batch Manufacturing Records (BMR) and supporting record review and approval (deviations, EM, analytical, OOS/OOT, etc.).
• Providing guidance on interpretation of European, UK, and US regulations, as well as harmonized guidelines like PIC/S and ICH.
• Keeping GMP knowledge up-to-date within the team and across other functions.
• Participating in self-inspections and external audits.
• Supporting regulatory inspections and audits by clients and partners.
• Maintaining QMS oversight as part of QP responsibilities, following EU GMP Annex 16 and QP Code of Practice.

We are looking for:

• A degree in Life Sciences or a postgraduate qualification.
• Experience and knowledge in biologics, sterile manufacturing, and dosage forms, especially those authorized under MHRA licenses, with a good understanding of Annex 1 EudraLex Volume 4.
• Expertise in GMP guidelines, validation, and Quality Management Systems.
• Knowledge of human clinical trials, IMPs, and medicines regulatory systems.
• Commitment to ongoing professional development to maintain QP status.
• Understanding of the legal requirements for QPs under EU and UK regulations.
• Experience in applying quality management principles across clinical and commercial phases.
• Familiarity with working with customers and partners in a contract manufacturing setting.
• Proficiency in eQMS and MS Office applications.
• Proven experience hosting regulatory inspections as a pharmaceutical auditor.

About Us:

Oxford Biomedica is a pioneering viral vector CDMO dedicated to enabling life-changing therapies. With over 25 years of experience, we specialize in viral vectors used in gene therapy, collaborating with leading pharmaceutical and biotech companies worldwide. Our capabilities span from early development to commercialization, supported by robust quality systems, analytical methods, and regulatory expertise.

What’s in it for you:

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

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