Quality Assurance Manager

• Review, implement and maintain the clinical trial Quality Management System (QMS). Make decisions regarding the structure of the QMS, where necessary consulting with the Quality Management Group (QMG) and other senior colleagues.
• Facilitate the writing and review of Polices, Standard Operating Procedures (SOPs) and supporting documents. Act as a final reviewer for SOPs and supporting documents to ensure that they have been written and reviewed in accordance with the QMS. With the BCTU Quality Management Group (QMG), determine which members of staff require training on each SOP document group. Decide on the most appropriate mechanism for creating these documents, where necessary contributing to personally writing documents.
• Ensure that Polices, SOPs and supporting documents are reviewed as defined in the SOP on SOPs
• Maintain oversight of SOP document training across the BCTU.
• Review the internal audit programmes. With the assistance of the quality management staff, plan annual audit programmes and maintain an overview of programme delivery.
• Manage the Quality Management Team.
• Ensure that monitoring requirements for each clinical trial protocol are assessed. Ensure that appropriate monitoring is conducted.
• Communicate relevant quality management issues and trial quality management. Report Serious Breaches to the QMG. Advise the QMG on changes to the statutory and regulatory framework where necessary making recommendations for changes in practice within the BCTU.
• Assist, and when required take a lead, on the preparation and review of reports, inspection dossiers and other formal written documentation.
• When required assist in the delivery of training (e.g. GCP, Quality Management, Regulatory Framework) to healthcare professionals, students and clinical trials staff.
• Establish and maintain links with QA Managers at other CTUs to ensure that there is effective liaison and sharing of best practice.
• Identify and resolve any reported deviations or serious breaches
• Liaise with auditors and (Medicines and Healthcare products Regulatory Agency (MHRA)) inspectors as required during audits and inspections of the BCTU QMS.
• Develop a national profile as an expert in clinical trials quality management. Contribute to local, national and international activities (e.g. within the University of Birmingham, National Institute for Health Research,European Medicines Agency, MHRA) through participation in national working parties, committees and by presenting at meetings.
• Any other duties commensurate with the grading of the post.
• Maintain confidentiality.
• Support the delivery of clinical research in accordance with Good Clinical Practice (GCP) as defined by UK Statutory Instrument 2004 No. 1031 and subsequent amendments, the Declaration of Helsinki, Data Protection Act 1998, Human Tissue Act, UK Policy Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research participant and the quality of each study and any other applicable regulatory equivalent

Person Specification

• Must be able to demonstrate experience in quality management within a quality assurance environment
• Experience of developing and/or maintaining quality management systems and writing SOPs is essential.
• Experience of staff management is also essential.
• A detailed knowledge of applicable regulations and guidance documentspertinent to clinical trials (e.g. Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, UK Policy Framework for Health and Social Care) is essential for this post.
• Must be able to demonstrate a good understanding of clinical research, audit and quality management procedures.
• Highly developed interpersonal, negotiation, presentation, and communication (written and verbal) skills are essential. Training or experience of managing difficult situations is desirable.
• Excellent organisational skills.
• Excellent IT skills. Familiarity with Microsoft Office: including PowerPoint and utilisation of advanced features of Word is desirable.Experience with Microsoft Access and/or Q-Pulse document management system would be an advantage.
• Able to work on own initiative and problem solve.
• Must demonstrate a critical and intelligent attention to detail with high standards of accuracy.
• Proven ability to work to strict deadlines.
• Must be able to work independently and as part of a team.
• Ability to travel nationally and internationally (on occasion) is essential.
• Ability to feedback constructively to trial teams on any findings at audit and be able to support colleagues to achieve excellence in quality.
• Must be able to demonstrate experience in quality management within a quality assurance environment