Process Compliance Manager
- Experience Level
Process Compliance Manager
A talented Manager is required to lead an established team of talented Process Compliance Officers who ensure overall GMP compliance of our cutting edge cell and gene therapy manufacturing department.
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.
Role and Responsibilites:
- Accountable for process compliance within the Manufacturing Department, to ensure the successful and timely release of production batches
- To ensure compliance with internal and external GMP requirements, resulting in successful regulatory audits, product license applications or renewal of regulatory product licenses
- Subject Matter Expert (SME) for Manufacturing CAPA / Deviation/ Change Controls and regulatory / customer GMP audits
- To ensure the implementation of process improvement initiatives within the Manufacturing Facility, with the intention of reducing / eliminating deviation (non-compliance) events
- To ensure the implementation and maintenance of a comprehensive and standardised training programme for the Manufacturing department
- Play a pivotal role in the investigation and analysis of deviation events, and be able to determine viable CAPAs to prevent recurrence
- Recognise process compliance deficiencies and implement appropriate process improvements
- Analyse trends in deviation events to monitor for recurrence, and implement initiatives to prevent repeat occurrences
- Accountable for leading, coaching, training and motivating a team of compliance officers direct reports and other staff members
- Planning and assigning work to the team to achieve the most effective use of personnel and resources.
Required Education & Knowledge
- Educated to degree level in a life sciences subject or possess sufficient industry experience.
- Knowledge of GMP production and regulatory standards from previous experience in a GMP facility.
- Previous experience managing and developing a team.
- Able to develop and maintain relationships and influence staff at all levels
- Computer literate, able to utilise Microsoft applications.
- Able to self-motivate and work autonomously to meet timelines.
We look forward to your application
No agencies please.