Quality Systems Officer

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 a Quality Systems Officer to join the Quality Assurance team. The purpose of this role is to design and provide continuous improvement of Quality Management Systems.

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:

• Monitor and produce metrics of GMP compliance with current Quality Management Systems
• Support all aspects of supplier qualification and ongoing risk management,
• Provide primary Quality support for all new products, projects, and suppliers/service providers.
• Conduct internal audits and follow up to promote continuous improvement,
• Perform Annual Product Quality Reviews
• Hosting of client and regulatory audits and inspections
• Support and co-ordinate responses to client and regulatory audits and inspections.
• Supports the quality of GMP manufacturing practices (i.e. aseptic practices) and or analytics during manufacturing/testing of drug/vector substance/product to ensure adequate and timely release of GMP compliant product in accordance with CTA, IND, and site-specific authorisations.
• Providing direct quality team support during customer and regulatory audits
• Create and maintain a state of readiness in order to satisfy regulatory and client expectations during audits and inspections.
• Work in a team in order to prepare and ensure the site systems are compliant and meet GxP and Quality expectations.
• Ensure that the manufacturing and or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
• Ensuring and coordinating training in all aspects of Quality Management Systems and Quality related GMP, including procedural updates.

We are looking for:

• A level or National Certificate in a Science discipline
• Higher National Certificate or Degree in science discipline desirable
• In depth knowledge of the pharmaceutical industry in terms of regulations and compliance
• Awareness and understanding of Quality Systems in order to support them effectively.
• Knowledge of GMP & Quality related pharmaceutical regulations & standards
• Computer literate (Word, Excel, MS Office).

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: Deliver Innovation, Be Inspiring and Have Integrity
• State of the art laboratory and manufacturing facilities

Collaborate. Contribute. Change lives.