Senior Process R&D Compliance Officer
Oxford Biomedica
Oxford, UK
Published 2 days ago
Business Compliance
Full time
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 senior R&D Compliance Officer to join the Process Development (PD) team. The purpose of this role is to ensure the timely reporting of project outcomes (technical reports, data presentations to clients, technical transfer documentation, or Process Characterisation protocols and reports) and to conduct timely investigation into project related excursions.
OXB's PD team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development, and analytical testing. PD take processes from the laboratory "bench" scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.
Your responsibilities in this role would:
OXB 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.
OXB 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. OXB'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:
We are currently recruiting for a senior R&D Compliance Officer to join the Process Development (PD) team. The purpose of this role is to ensure the timely reporting of project outcomes (technical reports, data presentations to clients, technical transfer documentation, or Process Characterisation protocols and reports) and to conduct timely investigation into project related excursions.
OXB's PD team consists of experienced scientists and engineers that have extensive expertise in all aspects of upstream and downstream development, and analytical testing. PD take processes from the laboratory "bench" scale and apply process expertise and engineering fundamentals for delivery to Manufacturing.
Your responsibilities in this role would:
- Conduct and co-ordinate data integrity checking of experimental records, technical reports, presentations, and other technical documents,
- Responsible for PD Data Integrity checking SOP. Author, review and approve departmental process compliance SOPs.
- Organise and facilitate individual and group training with regard to PD process compliance SOPs.
- Organise and facilitate investigations and root cause analysis into process deviations and laboratory excursions. SME in Root Causes Analyses and investigations.
- Identify and implement effective corrective and preventative actions to identified root causes. Track and trend departmental excursions and CAPA.
- Q-Pulse champion for PD- ensuring change controls, deviations and CAPA are correctly assigned, reviewed, and completed.
- Conduct regular inspections of the PD laboratories. Trend process excursions and implement mitigation plans to reduce laboratory errors.
- Lead updates to process documentation to capture new learnings and best practices.
- Lead and promote process improvement ideas to increase the department's efficiency and compliance.
- Lead inter-departmental process compliance / technical writing improvement initiatives.
- Provide mentorship to more junior process compliance officers, technical writers, and scientists. Where applicable, line manage more junior process Compliance officer(s) and / or technical writer(s).
- A degree in a science-based subject, and experience of working to GMP standard.
- Previous experience in the pharmaceutical industry/relevant in an MHRA/FDA regulated environment.
- Experience with documentation such as SOPs, Deviations, Risk Assessments, Technical Protocols and Reports.
- Experience of working within a process development laboratory, GMP manufacturing or a GLP environment.
- Experience in Root Cause Analysis techniques and the ability to amalgamate and interpret complex data in an investigative capacity.
- Able to support peers, team members and departmental representatives to get to the root cause of an issue using problem-solving tools.
- Ability to work collaboratively in cross-functional/departmental working groups.
- Computer literacy with demonstratable experience with MS Office Applications.
OXB 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.
OXB 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. OXB'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
- State of the art laboratory and manufacturing facilities