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 GCP / GLP Auditor to be involved in conducting and managing audit activities that serve to periodically assure compliance of the Clinical Operations, the organisation's offices and Vendors with company policies and procedures and applicable regulatory requirements.

Job Responsibilities:

• Leads audit planning, conducting and reporting of the organisations routine and non-routine audits of Clinical and non-Clinical Development activities, data, internal facilities and R&D processes in GxP to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. (This includes oversight of audits which are contracted out).
• In collaboration with the audited functions, advises and support in devising and executing remediation actions to ensure compliance to regulatory and Global Quality expectations and requirements.
• Approves CAPAs and regularly reviews progress and continue to give ongoing support in all compliance matters.
• Contributes in the continuous improvement and maintenance of a global GxP compliance platform for reporting, reviewing and trending Global Quality Audit KPIs.
• Assists QA Management the development/enhancement of a risk-based audit tool for prioritization of GxP audit activities.
• Advises, guides and supports sites in the overall regulatory inspection management (preapproval inspections, general GxP inspections) covering inspection preparations, execution, preparation of responses to health authorities and inspection follow-up as well as for key customer audits.
• Partakes in regulatory inspections in core and supporting roles. Assists with the preparation and delivery of training materials. Advises and contributes to coaching. Completes training requirements in a timely manner to ensure inspection readiness at all times.
• Assists QA Management with the development/enhancement of a risk-based tool for prioritization of GxP inspection readiness activities.
• Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents e.g. SOP's, Protocols, Guidance's, etc.
• Ensure own training is undertaken in a timely and GxP compliant manner before the task is undertaken.
• Ensure own KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.

Requirements:

• A minimum of a bachelor's degree is required.
• You will have 7-10 Years of Quality Assurance / Quality Systems experience in a GxP environment, clinical development, Medical Devices.
• 5 Years of Quality auditing experience.
• In depth knowledge with GCP/GLP guidance and regulations.

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.