Senior Quality Systems Officer

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

Oxford Biomedica’s Quality Assurance (QA) team is responsible for the company’s quality processes and systems, in compliance with GxP guidelines.  The team are accountable for overall quality compliance including QMS, Vendor Assurance, Internal and External audits Training and Risk Management.

We are currently recruiting for a Senior Quality Systems Officer who will be responsible for maintaining the Quality Management Systems (QMS) and Compliance, including Computerised System Validation (CSV) while promoting ongoing continuous improvement to meet business needs.

Your responsibilities in this role would be:

• Identify and lead QMS (Q-Pulse) improvement projects and procedures updates for Change Control, CAPA, Deviations and Supplier complaints.

• Review and approve CSV lifecycle documents and support CSV projects including the generation of process flows and Data Integrity Risk Assessments.

• Perform/support internal audits, supplier audits, client and regulatory audits/inspections, coordinate responses to audit observations and track the associated CAPA actions.

• Track, trend, and analyze quality system data, monitor Quality Metrics and communicate data compiled to relevant forums.

• Develop and deliver training programs on QMS and procedures for employees at all levels.

• Ensure data integrity compliance for paper based and electronic systems, including quality review of audit trail reviews with applicable requirements (e.g. 21 CFR Part 11 related to Computerised Systems).

• Perform supplier qualification, review supplier complaints, facilitate the review, update and approval of Quality/ Technical agreements with company critical subcontractors, service providers and material suppliers.

We are looking for:

• BS Degree in Biology, Chemistry, or similar Life Sciences related field and/or the appropriate amount of experience within the field.

• Significant Quality Systems experience within the biopharmaceutical industry

• Working knowledge of GMP & Quality related pharmaceutical regulations & standards.

• Experience of regulatory/client audits and inspections, investigations, and root cause analysis.

• Extensive working knowledge of data integrity computer systems validation (CSV) and Systems software development life cycle concepts.

• Ability to identify, prioritize, and implement actions to continuously improve Quality Systems.

• Problem solving skills with the ability to make informed decisions.

About Us:

We are a quality and innovation-led cell and gene therapy CDMO with a mission to enable our clients to deliver life changing therapies to patients around the world.

Our innovative solutions and proven expertise allow our clients in the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients.

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world’s worst diseases and medical conditions.

What’s in it for you:

• Highly competitive reward packages

• Wellbeing programmes

• Development opportunities

• A 35-hour working week

• Welcoming, friendly, supportive colleagues

• A diverse and inclusive working environment

• Our values are: Deliver Innovation, Be Inspiring and Have Integrity

• State of the art laboratory and manufacturing facilities

We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.

Collaborate. Contribute. Change lives.

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.