Sr/Quality Systems Officer, Compliance

Job description:

Do you pride yourself on your integrity? We do what’s right for employees, patients, and partners, and so can you.

We are currently recruiting for x2 Quality Systems Officer. Compliance to join the Quality Assurance team. The purpose of this role is to provide quality systems compliance support and guidance to OXB GXP functions in order to maintain compliance with the appropriate GXP regulations.

We are able to consider applications from persons with differing level of experience from an entry level Systems Officer to a Sr Systems Officer.

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:

• Responsible for partnering with the business to ensure procedures are aligned with regulatory and industry expectations and ensuring consistency across functions


• Collates, reviews and performs trending of quality metrics and works with QS Director to identify training and continuous improvement opportunities.


• Provides training for quality related topics including technical writing and root cause analysis.


• Supports process improvement projects impacting multiple functional areas.


• Perform audit trail reviews of GXP systems used across the business.

We are looking for:

• HNC/BSc Degree in a relevant Scientific discipline with technical and quality experience in the biopharmaceutical industry.


• Experience in the area of Quality Management Systems (QMS)/Pharmaceutical Quality Systems (PQS) would be beneficial.


• Comfortable working in a fast-paced environment.


• Understanding of Lean and/or Six Sigma principles


• Must possess a working knowledge of local and international GXP regulations and able to interpret these requirements.

About Us:

Oxford Biomedica 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.

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.

What’s in it for you:

• Highly competitive total reward packages


• Wellbeing programmes


• Development opportunities


• Welcoming, friendly, supportive colleagues


• A diverse and inclusive working environment


• Our values are: Responsive, Responsible, Resilience & Respect


• State of the art laboratory and manufacturing facilities

Collaborate. Contribute. Change lives.

Profile description:

Your responsibilities in this role would be:

• Responsible for partnering with the business to ensure procedures are aligned with regulatory and industry expectations and ensuring consistency across functions


• Collates, reviews and performs trending of quality metrics and works with QS Director to identify training and continuous improvement opportunities.


• Provides training for quality related topics including technical writing and root cause analysis.


• Supports process improvement projects impacting multiple functional areas.


• Perform audit trail reviews of GXP systems used across the business.

We are looking for:

• HNC/BSc Degree in a relevant Scientific discipline with technical and quality experience in the biopharmaceutical industry.


• Experience in the area of Quality Management Systems (QMS)/Pharmaceutical Quality Systems (PQS) would be beneficial.


• Comfortable working in a fast-paced environment.


• Understanding of Lean and/or Six Sigma principles


• Must possess a working knowledge of local and international GXP regulations and able to interpret these requirements.

About Us:

Oxford Biomedica 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.

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.

What’s in it for you:

• Highly competitive total reward packages


• Wellbeing programmes


• Development opportunities


• Welcoming, friendly, supportive colleagues


• A diverse and inclusive working environment


• Our values are: Responsive, Responsible, Resilience & Respect


• State of the art laboratory and manufacturing facilities

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.