Company description:
OXB 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, OXB has more than 30 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).
OXB 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. OXB'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
At OXB, 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 hiring a Quality Systems Team Leader to take ownership of our Quality Management System (QMS) and lead a dedicated team. This role will be responsible for ensuring inspection readiness, overseeing vendor management, driving risk management activities, and maintaining our training systems across the business.
Your responsibilities in this role would be:
Lead, support, and develop a team of Quality Systems Officers.
Oversee vendor qualification and monitoring.
Manage computerised system validation activities.
Plan and conduct internal and supplier audits.
Lead risk management processes and produce GMP metrics.
Maintain and improve the companys Quality Management System (QMS).
Perform annual product quality reviews.
Support and host client/regulatory audits, and coordinate responses to findings.
Create and review GMP documentation including SOPs, Deviations, Change Controls, CAPAs, Risk Assessments, and Supplier Complaints.
Drive continuous improvement initiatives across the QMS.
We are looking for:
A-Level education (science preferred) or equivalent experience.
Significant experience in a regulated environment, ideally within pharmaceuticals.
In-depth knowledge of GMP and Quality Management (QMS) principles.
An understanding and awareness of Computer Systems Validation (CSV).
Proven line management experience.
Ability to collaborate effectively, share information, and manage team workloads.
The ability to lead and conduct supplier audits.
Strong written and verbal communication skills (excellent English essential).
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
Profile description:
We are looking for:
A-Level education (science preferred) or equivalent experience.
Significant experience in a regulated environment, ideally within pharmaceuticals.
In-depth knowledge of GMP and Quality Management (QMS) principles.
An understanding and awareness of Computer Systems Validation (CSV).
Proven line management experience.
Ability to collaborate effectively, share information, and manage team workloads.
The ability to lead and conduct supplier audits.
Strong written and verbal communication skills (excellent English essential).
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
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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