Qualified Person

1 month ago

Oxford Oxfordshire Oxford Oxfordshire OX LT, Oxford, United Kingdom OXB Full time

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 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).


Profile description:

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


We offer:

Oxford Biomedica is a quality and innovation-led viral vector CDMO that enables its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, Oxford Biomedica has more than 25 years of experience in viral vectors, the driving force behind the majority of gene therapies.

Cell and gene therapy is the treatment of disease by the delivery of therapeutic genetic material (DNA or RNA), into a patient’s cells. One highly effective approach to delivering genetic information is to re-engineer existing viruses to be safe delivery vehicles (vectors) to insert the genetic material into patients’ cells. This can be achieved either by directly administering the vector to the patient (often referred to as in vivo gene therapy), or by first introducing the genetic material to cells or tissue outside of the body, before administering the cells or tissue into the patient (often referred to as ex vivo gene therapy or gene-modified cell therapy).

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 (AAV) 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.

  • Dispute Resolution Solicitor

    4 weeks ago

    Oxford, Oxfordshire, OX1, Oxford, United Kingdom G2 Legal Limited Full time

    Dispute Resolution Solicitor - Leading Law Firm in OxfordshireOur client, a renowned law firm based in Oxford, is nationally recognised for excellence in handling commercial and personal legal matters for a broad range of clients, including individuals, businesses, institutions, and non-profit organisations.Due to increased demand, its esteemed Dispute...

  • Private Client Solicitor

    4 days ago

    Oxford, Oxfordshire, OX1, Oxford, United Kingdom CapeClarke Limited Full time

    A leading law firm is seeking a Solicitor, Associate, or Senior Associate to join its growing Private Client team in Oxford. The successful candidate will provide high-quality legal advice to clients, ensuring commercial awareness and exceptional service. Additionally, the role involves supporting marketing initiatives and engaging in business development to...

  • Recruitment Consultant

    4 weeks ago

    Oxford, OX1 3HJ, Oxford, United Kingdom Manpower Internal Recruitment Full time

    Recruitment Consultant Location: Oxford Competitive Base Salary + Uncapped Commission Are you an experienced Recruitment Consultant with a proven track record of success in winning your clients and reaching targets? Or maybe you are a self-motivated individual with valuable experience within sales, customer service and administrative roles? We are looking...

  • Newly Qualified Personal Injury Solicitor

    3 weeks ago

    Oxford, United Kingdom JMC Legal Recruitment Full time

    Job Opportunity: Personal Injury Solicitor (NQ - 2PQE)Location: OxfordFirm: Top 100 Law FirmAre you a newly qualified to 2PQE Personal Injury Solicitor looking to elevate your career? Join our prestigious Oxford firm and take advantage of our clear progression framework designed to help you grow and thrive in your legal career.What We Offer:Competitive...

  • Newly Qualified Personal Injury Solicitor

    3 weeks ago

    Oxford, United Kingdom JMC Legal Recruitment Full time

    Job Opportunity: Personal Injury Solicitor (NQ - 2PQE)Location: OxfordFirm: Top 100 Law FirmAre you a newly qualified to 2PQE Personal Injury Solicitor looking to elevate your career? Join our prestigious Oxford firm and take advantage of our clear progression framework designed to help you grow and thrive in your legal career.What We Offer:Competitive...

  • Newly Qualified Personal Injury Solicitor

    3 weeks ago

    Oxford, United Kingdom JMC Legal Recruitment Full time

    Job Opportunity: Personal Injury Solicitor (NQ - 2PQE)Location: OxfordFirm: Top 100 Law FirmAre you a newly qualified to 2PQE Personal Injury Solicitor looking to elevate your career? Join our prestigious Oxford firm and take advantage of our clear progression framework designed to help you grow and thrive in your legal career.What We Offer:Competitive...

  • Newly Qualified Personal Injury Solicitor

    3 weeks ago

    Oxford, United Kingdom JMC Legal Recruitment Full time

    Job Opportunity: Personal Injury Solicitor (NQ - 2PQE)Location: OxfordFirm: Top 100 Law FirmAre you a newly qualified to 2PQE Personal Injury Solicitor looking to elevate your career? Join our prestigious Oxford firm and take advantage of our clear progression framework designed to help you grow and thrive in your legal career.What We Offer:Competitive...

  • Lead Qualified Person

    4 weeks ago

    Oxford, United Kingdom CV-Library Full time

    It's rare in the world of recruitment to get to represent a company that changes the world. I'm fortunate that the companies I tend to support all work within a world of life saving technologies and cutting edge science. The client that I am representing for this role is responsible for saving countless lives, and continues to produce immense...

  • Newly Qualified Personal Injury Solicitor

    2 weeks ago

    Oxford, United Kingdom JMC Legal Recruitment Full time

    Job Description Job Opportunity: Personal Injury Solicitor (NQ - 2PQE) Location: Oxford Firm: Top 100 Law Firm Are you a newly qualified to 2PQE Personal Injury Solicitor looking to elevate your career? Join our prestigious Oxford firm and take advantage of our clear progression framework designed to help you grow and thrive in your legal career. What...

  • SUPPLY Teaching

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Academics Ltd Full time

    Supply Teacher opportunity - Secondary School (all subjects) - Oxford Are you a qualified teacher looking for a more flexible way of working within Secondary Schools in Oxford? Academics Ltd are working with numerous, outstanding schools in and around the Oxford area who are looking to appoint supply teachers ASAP. As a Secondary Supply Teacher, you will...

  • Business Teacher

    2 weeks ago

    Oxford, Oxfordshire, United Kingdom Academics Ltd Full time

    Business Teacher (full time, part time, long and short term contracts) opportunity - Secondary School - Oxford Are you a qualified Business Teacher or Business Specialist looking for work within secondary schools in Oxford? Academics Ltd are working with an outstanding school in Oxford who are looking to appoint a Business teacher to join them from...

  • Part-time Contracts Lawyer

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Zest Recruitment and Legal Consultancy Ltd Full time

    Job Type: Permanent, Full-time On behalf of a respected and forward-thinking law firm, we are seeking an ambitious Solicitor (NQ-3 PQE) to join their growing Personal Injury team in Oxford. Collaborate with senior lawyers on a caseload of high-value clinical negligence and personal injury cases, providing accurate legal advice with commercial insight. ...

  • Vehicle Technician Weekends

    15 hours ago

    Oxford, Oxfordshire, United Kingdom Royal Mail Full time €45,000

    Location: Oxford Workshop Join the largest, and greenest, fleet operator in the UK and take on a new challenge in a commercial vehicle workshop environment. We’re recruiting an IMI Level 3 qualified mechanic at Oxford Workshop on a Permanent contract, with the potential to earn over £45,000 per annum including overtime. Working Hours: Full time - 39.5...

  • Workshop Controller Automotive

    2 months ago

    Oxford, Oxfordshire, United Kingdom Humand Talent Full time

    Workshop Manager - Be a Game-Changer in EV Technology! If you’re passionate about technology, sustainability, and making a difference, this role is perfect for you. Play an instrumental role in orchestrating the production of world class vehicles and products. Every vehicle you help build will contribute to reducing the carbon footprint and...

  • Solicitor

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Zest Recruitment and Legal Consultancy Ltd Full time

    Job Title: Solicitor (NQ-3 PQE) – Personal Injury Location: Oxford Job Type: Permanent, Full-time About the Role On behalf of a respected and forward-thinking law firm, we are seeking an ambitious Solicitor (NQ-3 PQE) to join their growing Personal Injury team in Oxford. This role presents a unique opportunity to work within a collaborative team,...

  • Supply Teacher

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Academics Ltd Full time

    Supply Teacher opportunity - Secondary School (all subjects) - Oxford Are you a qualified teacher looking for a more flexible way of working within Secondary Schools in Oxford? Academics Ltd are working with numerous, outstanding schools in and around the Oxford area who are looking to appoint supply teachers ASAP. As a Secondary Supply Teacher, you will...

  • Senior Sales Manager

    7 days ago

    Oxford, Oxfordshire, United Kingdom Brook Street UK Full time

    Our award-winning Estate Agency client are looking for a highly successful and experienced Senior Sales Manager to join their Summertown office. If you thrive on recognition and aspire to excel in everything you do, this is the perfect opportunity! Be part of a highly successful and expanding Estate Agency with a structured career path up to regional...

  • Estate Agency

    2 days ago

    Oxford, Oxfordshire, United Kingdom Brook Street UK Full time

    Our award-winning Estate Agency client are looking for a highly successful and experienced Property Manager to join their East Oxford office. If you thrive on recognition and aspire to excel in everything you do, this is the perfect opportunity! As a property Manager your responsibilities will include: * Provide a designated group of client's with...

  • Qualified Accountant

    1 month ago

    Oxford, United Kingdom CV-Library Full time

    Location: Newbury/Reading or Oxford Our client is a highly successful accountancy practice and due to continued growth they are seeking a newly Qualified Accountants. They are seeking accountants who have good financial modelling and data interpretation skills and who have a passion for working with businesses. You will be supporting advisory projects...

  • Recruitment Consultant

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Brook Street Internal Talent Full time

    Recruitment Consultant Location: Oxford Competitive Base Salary + Uncapped Commission Are you an experienced Recruitment Consultant with a proven track record of success in winning your clients and reaching targets? Or maybe you are a self-motivated individual with valuable experience within sales, customer service and administrative roles? We are...

  • Director of Co-Curriculum

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom Ad Warrior Full time

    Director of Co-Curriculum Location : Oxford Salary: Competitive The College School, founded in 1480 by William of Waynflete, is one of the countrys leading independent day schools. It is situated in an enviable location at the heart of Oxford beside the River Cherwell. Shaped by its Christian Collegiate foundation and links with the university city of...

  • Senior Sales Manager

    7 days ago

    Oxford, Oxfordshire, United Kingdom Brook Street UK Full time

    ?? Exciting Opportunity Alert! ?? Our award-winning Estate Agency client are looking for a highly successful and experienced Senior Sales Manager to join their Summertown office. If you thrive on recognition and aspire to excel in everything you do, this is the perfect opportunity! Be part of a highly successful and expanding Estate Agency with a...

  • Roadside Mechanic

    3 weeks ago

    Oxford, Oxfordshire, United Kingdom RAC Motoring Services Full time €33,000

    About The Role Roadside Mechanic - Oxford At RAC, we appreciate the dedication of our colleagues who go the extra mile for our customers. In return, we offer a competitive base salary of £33,000, complimented by an average OTE ranging from £41,000 to £51,000. I n addition to this, you'll also enjoy all of these extra benefits: Colleague Share...