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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 in this role 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.
* Providing input on quality decisions and strategies, balancing quality with business objectives.
* Participating in project meetings, client, and partner meetings.
* Serving as a key contact for external QA parties.
* Acting as EU Qualified Person (QP) for batch certifications in accordance with relevant regulations.
* Overseeing Batch Manufacturing Records (BMR) and supporting record review and approval (deviations, EM, analytical, OOS/OOT, etc.).
* Providing guidance on European, UK, and US regulations, as well as harmonized guidance like PIC/S, ICH.
* Ensuring GMP knowledge is up-to-date within the team and 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 (EU GMP Annex 16 and QP Code of Practice).
We are looking for:
* A degree in Life Sciences or a postgraduate qualification.
* Experience in biologics and sterile manufacturing, preferably with MHRA-authorized IMPs or APIs, including knowledge of Annex 1 EudraLex Volume 4.
* Expertise in GMP guidelines, validation, and Quality Management Systems.
* Knowledge of human clinical trials, IMP, and commercial medicines regulatory systems.
* Commitment to professional development to maintain QP status.
* Understanding of the requirements for Qualified Persons as per relevant EU directives and UK regulations.
* Extensive knowledge of quality management principles within a GxP environment.
* Familiarity with working with customers and partners in a contract manufacturing setting.
* Proficiency in eQMS and MS Office applications.
* Proven experience as a pharmaceutical auditor, including hosting regulatory inspections.
About Us:
OXB is a quality and innovation-led viral vector CDMO with a mission to enable its clients to deliver life-changing therapies. With over 25 years of experience in viral vectors, we are pioneers in cell and gene therapy, collaborating with leading pharmaceutical and biotech companies worldwide.
What’s in it for you:
* Highly competitive total rewards
* Supportive and friendly colleagues
* Diverse and inclusive environment
* State-of-the-art facilities
We aim to inspire you daily. Join us as we grow and succeed together through passion, commitment, and teamwork.
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