Clinical Quality Manager - GCP
Salary details available on discussion + 20% bonus
Life Science People are exclusively retained on a Clinical Quality Manager opening with a Cell & Gene therapy company going through a sustained period of growth. The role can be home based (with travel to the office when required), fulltime (37.5 hours per week) and a permanent contract.
If you are looking for the opportunity to develop yourself, a team and a department then this could be just the role for you. With excellent development opportunities including the chance to build your GMP exposure and skillset and the chance to be part of this rapidly expanding biotech, now really is the time to get in contact to explore further.
The role will be responsible for all day-to-day quality and compliance activities relating to clinical trial activities being conducted by the company and our vendors as well as supporting laboratory exploratory analysis of clinical trial samples. You will support the establishment of and management of the PQS in relation to GCP activities including writing, reviewing, approving and maintaining SOPs and other clinical documentation, working closely with the clinical team to provide quality oversight of vendors and addresses any quality related issues that arise. On top of this you will coordinate the implementation of the company PQS relevant to GCP including external vendor oversight, training on quality procedures and monitor performance against agreed standards.
Other key responsibilities will include:
- Assist with the selection and leads the qualification process for external vendors and with clinical operations provides oversight for outsourced contracted clinical activities;
- Contributes to the establishment, development and day-to-day management of a cross company GXP PQS including document control, risk management and CAPA management to ensure clinical quality requirements are fit for purpose and are appropriate for clinical phase;
- Provide GCP, GLP and GCLP guidance as appropriate to clinical project teams, including risk identification and mitigation of potential identifiable operational issues and or deviations;
- Serves a Clinical Quality Lead for clinical trial programs;
- Establishes audit plans and leads, participates or manage audits including follow-up to include internal, vendors, clinical sites, external laboratories and suppliers;
- Plan, implement and deliver regular GCP training and other relatable quality training;
- Assist in inspection readiness preparation and directly support regulatory agency inspections;
- Maintain and develop the QMS to ensure ongoing compliance with regulatory standards and regulations;
- Identify and monitor quality indicators and data to identify potential trends and risks to patient safety, compliance, data integrity to the business and promote improvements where necessary;
Successful applicants must be able to demonstrate extensive clinical quality experience as well as a strong understanding of pharmaceutical QA, GCP and cell & gene therapy practices within a clinical quality/pharmaceutical clinical/laboratory environment (5 years) ideally as well as experience of both developing audit procedures, to include hosting and conducting across local and global regions.
You must also be able to show:
- Experience supporting clinical laboratories (advantageous);
- Experience providing quality support for Cell and Gene Therapy programmes;
- Demonstrated knowledge, understanding and application of GCP guidelines and regulations;
- Fluent English communications skills (written & spoken).
- Experience of vendor oversight especially CROs and external laboratories;
- Expert knowledge of pharmaceutical regulations, standards and current industry regulatory practices related to GCP with an understanding of ATMPs;
To apply for this role, please email your CV to Bob Beevers at Life Science People on or connect with me on LinkedIn and send me a message https://www.linkedin.com/in/bob-beevers-15432a167/
If this role is not for you, I would appreciate you sharing the details with anyone that you believe would be suitable and interested.
Please note that the successful applicant must be eligible to work in the UK without sponsorship and have the ability to travel freely in Europe.