Quality Systems Officer

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-changingtherapies to reach patients around the worldand were looking for passionate individuals who embody our core values every day:Responsible, Responsive, Resilient, and Respectful . We are currently recruiting for a Quality Systems Officer,responsible for maintaining the Quality Management Systems and promoting continuous improvements to meet the business needs Your responsibilities in this role would be: Provide primary Quality Systems support for, materials, suppliers and services providers Maintain supplier and internal audit schedules Provide Quality Systems input to annual Quality Reports Facilitate updates into Quality/Technical Agreements Review Deviations, CAPAs, Change Controls and Supplier Complaints Review Computer Systems Validation (CSV) documents Identify and lead QMS improvements Monitor and produce metrics for GMP compliance Deliver training on QMS Profile description: We are looking for: A-Level education in (science preferred) or equivalent experience Experience working within a GMP-regulated environment Knowledge of pharmaceutical regulations and compliance requirements Experience within Quality within a pharmaceuticals environment Hands-on experience using electronic Quality Management Systems (eQMS) to GMP standards. An understanding and awareness of Computer Systems Validation (CSV) An understanding of Quality audits, investigations, and root cause analysis and change Control Processes Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint) Proven knowledge and application of GMP and wider pharmaceutical Quality standards. Awareness of Quality Systems with the ability to support and improve them effectively 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 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.TPBN1_UKTJ