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Head, Clinical Compliance will be responsible for ensuring compliance across all clinical trials including clinical trial sites and vendors.
This role is key in promoting quality awareness across Clinical Operations and all associated activities and developing and maintaining company GCP, GCLP, GLP, GDP, GVP and GMP.
The job holder will be responsible for maintaining and optimising an efficient Clinical Quality Management System. This is a key role.
Head of Clinical Compliance will provide Quality Management input and oversight of Clinical Operations located across Europe and US.
This role will require the holder to be proficient in GxP Quality Systems, particularly associated with Clinical Operations, SOP Management, CAPA management and Training for clinical trials within the CAR T setting.
The position will have a dotted reporting line to Head of Quality.
Lead the Clinical Compliance team ensuring global clinical trials are conducted by Autolus with the current applicable SOPs, regulations and guidelines on Good Clinical Practice (GXP)
Ensure that all processes and related tasks are in compliance with regulatory and GxP guidelines
Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies
Perform selection audits, qualify and monitor compliance to qualification requirements.
Manage quality issues in collaboration with internal Autolus teams to ensure expedited correction and preventative measures.
Manage the Global Clinical compliance team and any Consultants
Report audit trends and recommendations, including potential high-risk areas to senior management on a regular basis
To provide objective assurance via Key Performance Indicators (KPI) to Autolus management that quality standards employed during the trials will enable clinical and post-marketing data to be acceptable worldwide for regulatory licensing purposes
Strategically risk assess and report to Head of Clinical Operations and Head of Quality, the risk of any critical or major audit finding identified in Programme audits including Investigator Site, Vendor, Clinical Research Organisation (CRO) or Internal Process / System audits
Provide guidance on the design, implementation and reporting of all clinical trials to the current regulations / guidelines
Advise and assist Autolus employees and Clinical Investigators in their written responses to the Regulatory Agencies or other external agencies as a result of inspections and external audits
Provide a framework for continuing quality improvement in GCP, GCLP, GLP and GVP activities
Act as the functional representative for Clinical Operations at the company Quality Board
Manage activities relating to Regulatory Inspections for GCP
Manage and oversee the overall clinical audit programme, including internal systems, suppliers / vendors, documentation / submissions and investigator site audits for clinical operations
To manage and oversee out-sourced clinical compliance auditing activities
Oversee the development of appropriate Audit Plans for each Audit Programme, working with partners where appropriate
Act as Inspection Lead / Host for GCP inspections, and for external audits
Manage the development of Clinical Quality Assurance audit plans, in collaboration with Head of Quality
Prepare the Compliance Reports for GCP activities and submits to MHRA
Oversee the CAPA process and ensure that CAPAs are assigned an owner and closed out appropriately and in a timely manner