QA Compliance Lead (GCP)
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Hobson Prior is currently working with a gene therapy organisation who are determined to develop possible curative treatments for patients who are living with serious illnesses. This innovative company is seeking a QA Compliance Lead (GCP) to support the development and maintenance of the Quality Management System related to Clinical operations ensuring it is implemented, inspection ready and maintained in a state of control in compliance with applicable national and international GxP rules and regulations.
- Deliver expertise and oversight for GCP, ensuring that the quality and compliance of Development and Clinical Trails Studies, products and programs (Phase I-IV) meet with regulatory requirements
- Assist with the development of the organisation's QMS for Clinical Operations for all GCP related activities to ensure compliance with GxP regulations is maintained through implementation of appropriate processes, risk assessments, gap assessments and training.
- In partnership with the Clinical Operations department drive the implementation of the GCP phase appropriate Quality Management System to achieve a high level of quality and compliance for development Research Studies, products and programs.
- To streamline and improve Clinical quality processes.
- Support, plan and host self-inspections and regulatory inspections.
- Accountable for systems and processes around internal retention and archiving for Quality Assurance and Clinical Operations documentation and effectively manage the strategic operation of third-party Archiving Facility and processes.
- Offer QA GCP support and oversight to the UK Clinical Operation team, ensuring compliance with EU, UK and FDA cGCP regulatory requirements, QMS and any other applicable regulations/standards.
- QA review and approval of GCP quality documentation generate by UK Clinical Operations team e.g. but not limited to Deviations, CAPAs, Change Controls, SOPs, risk assessments etc.
- Generate and prepare quality documents e.g. SOP's and controlled documents.
- Work with the Clinical Operations team and GCP QA Audit Team to provide and support for quality and compliance in relation to GCP matters.
- Support, plan and host internal/external audits and regulatory inspections in coordination with the Clinical Operations team and QA Audit Team.
- Proactively coordinate and oversee responses from of Audit Observations, GCP quality investigations as needed e.g. deviations, serious breaches, and assist with the CAPA Development (where necessary this could be in conjunction with nominated third parties).
- Responsible for providing oversight and follow up of CAPAs from audits and Quality Issues in GCP and maintain KPIs for all GCP activities in conjunction with Clinical Operations personnel to monitor and ensure compliance on an ongoing basis.
- Good organisational and time management skills and able to demonstrate flexibility and adaptability.
- Able to prioritise workload, decisive thinker able to work within agreed timescales.
- A high Level of attention to detail.
- Degree in Life Sciences or similar related field.
- At least 5 years proven experience in the pharmaceutical industry in a relevant field such as GCP Compliance quality assurance, regulatory drug safety, clinical development or a directly related area.
- Extensive experience in clinical research & GCP.
- Good working knowledge and understanding of pharmaceutical Quality Assurance and GCP experience within a clinical trails and operations environment.
- Good understanding and working knowledge of preparing SOP's and with reviewing and approval of devaitions, CAPA, Change Controls etc.
- A working knowledge of other GxP areas is also desired.
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.
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