GCP QA Manager

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GCP QA ManagerI am currently working with an exciting Biotech based in Hertfordshire who are looking for a GCP QA Manager manager to join the team at their state of the art facility.Reporting to the Head of QA, as GCP QA Manager you will be in a Quality Assurance role that will provide Good Clinical Practice support programmes at clinical-stage programmes through the development, implementation, and execution of global clinical processes and Quality Systems.GCP QA Manager ResponsibilitiesProvide support, guidance, and oversight for clinical studies with focus on compliance with Good Clinical Practice (GCP)'s regulations and guidances.Provide expert Good Clinical Practice (GCP) advice and work closely with functional groups to address compliance and quality assurance trends across clinical trials.Author, review and/or approve clinical SOPsReviews applicable clinical documents for accuracy and internal consistency as it applies to qualityEnsure clinical trials are conducted in accordance with protocols, GCP guidelines, and applicable regulatory requirements.GCP QA Manager Requirements:Extensive experience in a QA function, preferably in the pharmaceutical / biotech industry with focus in clinical development and operations.QA GCP experience. Minimum of 5 years' experience in pharma / biotech in a GCP role are requiredExcellent knowledge of Clinical Trials Regulations and guidances, including FDA, ICH, WHO, or equivalent.Experience and ability to conduct and lead audits.Gene therapy experience is a plus , especially in early phase trials.If this GCP QA Manager role looks like it could be the next step in your career, please get in touch as soon as possible! To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales