Company description:
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 patients 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.
Job description:
Join Us in Changing Lives
AtOXB, our people are at the heart of everything we do. Were on a mission to enable life-changing therapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful.
Were currently recruiting for a Senior Quality Systems Officer to join our QA team. In this role, you will be responsible for maintaining the Quality Management Systems (QMS) and Compliance (including CSV - Computerised System validation) at Oxford Biomedica and will promote ongoing continuous improvement to meet business needs.
Your responsibilities in this role would be:
* Leading improvements to the Quality Management System (QMS), driving projects, updates, and compliance monitoring.
* Managing supplier qualification and maintenance
* Reviewing and approving Quality records, including Deviations, CAPAs, Change Controls, and CSV lifecycle documents.
* Managing the change control process to assess impact and ensure regulatory compliance.
* Providing Quality support for new products, projects, suppliers, and service providers, including qualification and complaint management.
* Coordinating and supporting internal, supplier, client, and regulatory audits, including follow-up actions and CAPA tracking.
* Contributing to wider Quality initiatives such as Annual Product Quality Reviews, Management Review Forums, and regulatory gap analyses.
* Delivering training on Quality Systems and ensuring data integrity across both paper-based and electronic systems.
We are looking for:
* Significant experience in Quality Systems within the biopharmaceutical/pharmaceutical industry, with a strong understanding of GMP and regulatory standards.
* Proven background in Pharmaceutical QA, including audits, inspections, investigations, root cause analysis, and change control.
* Experience managing electronic Quality Management Systems and document/records management in a regulated environment.
* In-depth knowledge of data integrity, computer systems validation (CSV), and software development lifecycle concepts.
* Strong IT skills, including advanced use of Microsoft Office (Word, Excel, and related tools).
* Ability to identify, prioritise, and drive continuous improvements in quality systems.
* Ability to identify, prioritize, and implement actions to continuously improve quality systems.
Profile description:
About us:
OXB is a quality and innovation-led viral vector CDMO 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.
OXB collaborates with some of the worlds most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXBs 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.
Why join us?
* ??Competitive total reward packages
* ??Wellbeing programmesthat support your mental and physical health
* ??Career development opportunitiesto help you grow and thrive
* ??Supportive, inclusive, and collaborative culture
* ??State-of-the-art labs and manufacturing facilities
* ?? A company that lives its values:Responsible, Responsive, Resilient, Respect
We want you to feel inspired every day. At OXB, were future-focused and growing fast. We succeed togetherthrough passion, commitment, and teamwork.
Ready to Make a Difference?
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 patients 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.
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