Hobson Prior have an opportunity for a GCP QA Manager to join a clinical-stage biotechnology organisation based in Stevenage. Our client concentrates on developing pioneering gene therapies to enable people living with chronic diseases live a better life.

Job Responsibilities:

• You will work with the clinical development functions to ensure that the organisations clinical trial operations are conducted in accordance with the relevant GCP requirements.
• Monitoring and approval of GCP service providers.
• Work alongside the Clinical Operations team and provide GCP QA support and guidance as required.
• 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.
• Accountable for GCP aspects of the 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.

Key Skills:

• You will have excellent working knowledge and understanding of GCP requirements.
• Strong verbal and written communication and computer literacy skills.
• Excellent interpersonal and time management skills.

Requirements:

• Educated to degree level or equivalent.
• Competent Authority (e.g. MHRA, US FDA) inspection experience.
• Previous experience in the pharmaceutical industry, minimum seven years GCP QA experience of which at least five must be working with IMPs.
• Prior experience auditing GCP service providers.
• Familiarisation with Microsoft Office applications (specifically Word and Excel).
• Ability to travel to work partners in Europe and US as the role requires.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.