Quality Systems Director - Complianc

Job description:

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 Quality Systems Director. The role will be responsible for providing quality systems compliance support and guidance to OXB GXP functions in order to maintain compliance with the appropriate GXP regulations. The role will report directly to the VP, HOD of Quality.

Oxford Biomedica’s Quality 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:

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


• Promoting a positive QA culture and providing QA direction for business and operational decisions.


• Develop and performance manages a high performing team of Quality Officers and provides coaching/mentoring to others as appropriate.


• Working with the GXP functions to maintain and continually improve the quality system to enable the development, manufacture and analytical testing of low bioburden and sterile products.


• Providing oversight of the collation, review and trending of quality metrics and identifying training needs.


• Communicating quality metrics, actions and recommendations at the appropriate forums including Quality Review Management Forum.


• Identifying and leading process improvement projects impacting multiple functional areas.


• Responsible for the performance management of Quality Systems Officers and provides mentoring/coaching of others as appropriate.


• Ensure there is a process in place for QA to perform audit trail reviews of the GXP equipment in use across the business.

Profile description:

We are looking for:

• BSc Degree in a relevant Scientific discipline with several years of technical and quality experience in the biopharmaceutical industry.


• Management/Leadership experience in the area of Quality Management Systems (QMS)/Pharmaceutical Quality Systems (PQS).


• Comfortable working in a fast-paced environment.


• Experience of Lean and/or Six Sigma principles


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


• Excellent interpersonal skills with the ability to be able to develop and sustain strong working relationships.


• Able to positively influence decisions both cross functionally and with external stakeholders.

About Us:

Oxford Biomedica is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) 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, 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 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.