Quality Assurance Manager (fixed contract  until march 2022)

Please proceed if you have the following 

• Excellent knowledge of ICH GCP, EU clinical trials legislation and UK clinical trial regulations
• Experience of managing and implementing quality control and quality assurance systems within a clinical research setting
• Experience in planning, conducting and reporting GCP audits
• Knowledge of clinical trials in all phases
• Experience of writing concise and pertinent reports
• Experience in delivering training and developing training materials
• Experience of managing and implementing quality control and quality assurance systems within an academic clinical trials unit
• Experience in hosting or participating in regulatory inspections
• Experience of working in an environment allied to the NHS

Here's an idea of what you will be doing:

As the QA Manager you will have overall responsibility for the quality management systems and quality assurance processes.

You will be responsible for developing, monitoring and enhancing the quality management policies and procedures for the Unit and will be the central point of contact for advice and guidance on all quality assurance related issues.

This is largely a self-directed role and although there will be close working relationships with the Heads departments you will make autonomous professional decisions on a daily basis relating to the initiation, development and implementation of quality assurance systems.

As the QA Manager you will consequently recognise and act upon breaches of legislation related to clinical trials, responding appropriately and escalate action as required.

You will ensure that systems and processes in place to demonstrate that personnel employed in the unit are appropriately qualified and trained, and that trials are conducted, and data processed in accordance with International Conference on Harmonisation (ICH) GCP, Statutory Instrument (SI) 2004/1031 and subsequent amendments and any other relevant regulatory requirements.

They have implemented the Q-Pulse electronic Quality Management System for management of SOPs and WIs, including tracking, distribution and release. As system owner, the QA Manager will be responsible for overseeing Q-Pulse QMS activities and ensuring these are utilised to support regulatory compliance. So you should already be familiar with this.

The QA manager has line management responsibility for a QA Administrator who supports the above activities.

Key Responsibilities:

• Lead and maintain an effective Quality Management System which will include identifying gaps and changes required within the QMS and taking the lead to implement these changes.
• Establish planned and systematic actions to ensure that clinical trials on the portfolio are performed, and the data are generated, documented and reported, in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
• Provide expert advice in Good Clinical Practice (GCP) to all ICTU and affiliated personnel
• Keep abreast of requirements of GCP, European and UK regulations which apply to clinical trials, and ensure personnel are notified of any significant changes
• Ensure systems and processes in place to ensure that appropriately qualified and trained personnel are employed, trials are conducted, and data processed in accordance with ICH GCP and regulatory requirements
• Ensure all staff are appropriately trained and informed to the level required for the effective and compliant conduct of their work
• Contribute to the maintenance of full Clinical Trial Unit Registration status
• Ensure effective preparation, conduct and closeout of all internal and external audits including those by by third parties looking to work with them.
• -Conduct regular internal audits of studies and processes, identified following a risk-based approach. Also act as the main point of contact for internal audits and reviews by the Joint Research and Compliance Office.
• -Ensure effective preparation, conduct and closeout of all inspections of by the MHRA and other regulatory authorities.
• -Act as the main point of contact for regulatory inspections of the clinical trials unit by the MHRA and other regulatory bodies and liaise with JRCO as the main point of contact for regulatory inspections of the Sponsor.
• Prepare and present regular reports to the Unit Management Team and Scientific Management Board in order to ensure that the Director,