Oxford BioMedica is a pioneer of gene and cell therapy and our work is helping to deliver life changing treatments.

Gene and cell therapy is the treatment of disease by the delivery of therapeutic DNA into a patient’s cells, providing long term and potentially curative treatments for a wide range of diseases. With the potential to transform medicine, the sector holds significant promise with the first commercial products now launched and others rapidly approaching the market.

Our recent successes are driving significant growth. As such, we are looking to recruit a Senior QA Officer, Vector Product Operations.  The purpose of this role is to initially provide QA support to the design, build, commissioning / qualification and licensing for a new vector production and aseptic finishing facility.  Once the build is complete, to line manage a team of QA Officers in the aseptic processing team to support the manufacture of all final sterile products.  In addition, you will be responsible for monitoring, advising and supporting operations to ensure regulatory compliance and to facilitate product release in a timely manner, as well as, maintain a strong QA culture throughout the business providing guidance in accordance with GxP compliance requirements.

Key responsibilities and accountabilities:

• Oversee quality of GMP fill and finish / sterile manufacturing operations on-site and at CMOs to ensure adequate and timely release of GMP compliant product
• Provide direct quality team support during customer and regulatory audits
• Ensures that all manufacturing documentation e.g. BMR’s, reports are reviewed and approved on batch completion, and forwarded to QP for on-time batch release.
• Review Quality systems documentation including Deviations, Change controls and CAPA’s.
• Investigate problems in conjunction with Manufacturing/ Analytics and other subject matter experts to determine corrective and preventive actions.
• Review Risk Mitigation documentation, validation documents, FMS and Engineering documents, Lab OOS, SOP’s, and Policies.
• Supporting quality related customer complaint investigations and trending activities.
• Monitoring the progress of GMP regulated manufacturing and/or GMP analytics processes through all departments to ensure compliance with specifications and GMP.
• Provides line clearance checks including pre-batch manufacture or testing walk rounds at appropriate and quality critical stages of the batch manufacturing / testing process.
• Participate in continuous improvement initiatives to enhance working practices and to mitigate quality risks.
• Supporting Quality based projects working as part of a multidisciplinary team as required.
• Promoting continuous improvement of the Quality Management System.
• Ensure that the manufacturing and/or analytics sites follow all SOPs which ensure that health, safety, environmental, quality standards are met.
• Ensuring the effective communication of key information affecting product release to all relevant parties.
• Reports on-going progress with QA activities and Deviations to QA Manager.
• Lead and communicate minutes of Interface meetings.

Key skills and requirements:

• Solid working knowledge of GMP & Quality related pharmaceutical regulations & standards including cleanroom design, classification and environmental control / monitoring.
• Experience of MHRA and or customer / client inspections.
• Experience of having worked in an ATMP / Biologics Manufacturing environment preferable.
• Previous experience of cleanroom design, build and commissioning preferable.
• Computer literate (Word, Excel, MS Office)

Person Specification:

• Significant experience working within Pharmaceutical QA including experience of supporting validation and sterile operations.
• Understanding & experience of GMP and pharmaceutical industry QA requirements.
• A level or National Certificate in a Science discipline.
• Higher National Certificate or Degree in science discipline desirable.
• Line management experience.
• Excellent attention to detail.
• Good interpersonal and communication skills.
• Good team player, and must also be able to work alone.
• Good organisational and time management skills.
• Competent in prioritising workload, a decisive thinker and able to work within agreed timescales

No agencies please