Qualified Person (QP).

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 performing batch certification and helping to 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 are accountable for internal and external audits, quality compliance and control.

Your responsibilities in this role would be:

• Certifying that Investigative Medicinal Products (IMPs) and/ or commercial API are manufactured in accordance with Good Manufacturing Practice (GMP.
• Participation within the Quality Assurance (QA) Leadership / Steering Team.
• Inputting on quality policy, objectives and deliverables for business.
• Inputting on quality decisions and go-forward strategies, balancing quality with business objectives.
• Participation at project meetings, client / partner meetings
• Be a key point of contact for external parties for QA.
• Serving as EU Qualified Person (QP) for batch certifications in accordance with 2001/83/EC, Regulation 536/2014 and SI2012-1916
• Overseeing BMR and supporting record review and approval (deviations, EM, analytical, OOS/OOT etc).
• Providing guidance and interpretation of European, UK Statutory Instruments and USA regulations as well as other harmonised guidance’s like PIC/S, ICH, etc.
• Ensuring GMP knowledge of self and others within both the Quality team and other function are kept up to date.
• Participate as required in self-inspection activities and external audits
• Host and support regulatory inspections, audits by clients / partners.
• Maintain QMS oversight as part of QP operational responsibilities (EU GMP Annex16 and QP Code of Practice).

We are looking for:

• Life Science and/ or post graduate degree.
• Knowledge and experience in biologics and steriles (preferably aseptic) manufacture and dosage forms to be named on MHRA issued Manufacturer’s Authorisations for IMPs (or commercial API), inclusive of excellent working knowledge and interpretation of Annex 1 EudraLex Volume 4.
• Expert knowledge of the Current Good Manufacturing Practice Guidelines.
• Expert knowledge of Validation and Quality Management systems.
• Working knowledge of Human Clinical Trials, IMP, and commercial Medicines Regulatory system.
• Requirements of continuing professional development to maintain QP status
• Requirements of the Qualified Person as detailed in articles 48, to 53 of Directive 2001/83/EU and Medicines for Human Use (Clinical Trials) Regulation (UK Statutory Instruments 2004 No. 1031) and EudraLex Vol 4 part 4
• Extensive knowledge, interpretation and application of quality management Principles within a GxP environment for early phase clinical trials through to commercialisation.
• Computer Literacy skills within eQMS & MS Office applications.
• Proven experience as a Pharmaceutical Auditor hosting regulatory inspections

About Us:

Oxford Biomedica is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 25 years of experience in viral vectors; the driving force behind the majority of gene therapies.

Oxford Biomedica collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus, and adenoviral vectors. Oxford Biomedica’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

What’s in it for you:

• Highly total reward packages
• Wellbeing programmes
• Development opportunities
• Welcoming, friendly, supportive colleagues
• A diverse and inclusive working environment
• Our values are: Deliver Innovation, Be Inspiring and Have Integrity
• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.

Collaborate. Contribute. Change lives