Reference Number: JO-2003-447922
QA Manager GCP
Job Type: Permanent
Quality Assurance Manager (GCP)
Salary details available on discussion
My client is a leading clinical-stage biotechnology company based in Hertfordshire who are currently seeking an experienced Quality Assurance Manager, to join their business on a permanent working basis. The company specialise in the development and commercialisation of innovative gene therapies to change patients lives globally and are looking to grow substantially over the coming years through targeted approach to liver based diseases.
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 internal process improvement opportunities and the chance to be part of the global QA senior leadership team with commercial and operational oversight, now really is the time to get in contact to explore further.
The role will be responsible for reporting directly to the Director of Quality and will take responsibility for all Quality activities related to the development and progression of the quality function to include; design, development, delivery and execution of the quality management system including audit and inspection management, QMS management, GCP oversight and lead on the assurance of compliance for all projects, products and programs. PLEASE NOTE: This role will require travel globally.
Other key responsibilities will include:
Facilitating the development, planning and co-ordination of company SOPs and on-going maintenance and revisions.
Ensuring QA involvement is targeted to business needs.
Work alongside the Clinical Operations team and provide GCP QA support and guidance as required
Monitoring and approval of GCP service providers
Assist QA Director with compilation of GXP audit plan
Conduct external audits of GCP service providers
Conduct internal audits of QMS elements and selected GCP processes
Co-host Competent Authority inspections by GCP Inspectorates
Represent QA at Clinical Operations project meetings
Responsible for GCP aspects of the Freeline QMS
Review clinical SOPs, protocols, investigator brochures, informed consent forms, patient information leaflets and other participant and trial related documentation for consistency and compliance with GCP
Provide GCP QA input into Change Controls, Deviations, investigations and CAPAs related to GCP activities
Deliver GCP training
Facilitate Sponsor release of ATIMPs
Other QA tasks as required
Support formal training programmes by highlighting QA training requirements and act as a trainer on QA issues and regulations.
Successful applicants must be able to demonstrate IMP experience as well as strong understanding of pharmaceutical QA, GCP and QMS experience within a clinical trial/clinical operations environment ideally as well as experience of both developing audit procedures, to include hosting and conducting across local and global regions. Candidate will also ideally have ATIMP experience and or understanding.
You must also be able to show:
The ability to establish and maintain effective working relationships with internal and external stakeholders.
Extensive/demonstratable knowledge of clinical pharmaceutical procedures.
Demonstrated knowledge, understanding and application of GCP guidelines and regulations.
Fluent English communications skills (written & spoken).
Ability to interpret complex data and present key findings.
To apply for this role, please call Bob Beevers at Clinical Professionals on +44 207 822 1710 or send an updated version of your CV via email to email@example.com
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.
Candidates must be eligible to work on a permanent basis within the UK without sponsorship.