Senior Quality Assurance

1 month ago

Ellesmere Port Cheshire, United Kingdom SRG Full time

Here at SRG, we are proud to be partnering with this innovative healthcare company. They are the UK’s leading supplier of mobile facilities that relieve hospital capacity and support vital clinical research. They partner with NHS trusts and private healthcare companies across the UK and offer a wide variety of services.
Due to company growth, they are looking for a quality and compliance leader to come in as their Head of Quality Assurance to oversee all the operational and clinical quality functions within the company. You will be working closely with the COO and managing and building the quality department.

Build, manage, lead and motivate an integrated, inclusive and flexible team, ensuring that people with the right range of skills and experience are recruited and retained, and that their skills and professional capabilities are maximised.
Provide effective direction, leadership, and development of the quality team (QA and QC) in support of the business as a whole.
Develop, implement and maintain the Quality Management System (QMS) with the Quality Team and take the lead in presenting it to clients in contractual negotiations.
Responsible for the continuing development and promotion of a proactive quality assurance framework across the company.
Provide governance of, and support to ensure ongoing compliance of the Quality QMS with all applicable standards and guidelines in clinical services and clinical trials.
For clinical trials, develop and implement a risk-based and flexible approach to Quality Assurance (QA) within the company, which will ensure that trial participants and data are safeguarded in compliance with applicable regulatory requirements and best practice.
Work with training and monitoring colleagues, to implement, review and maintain tracking of incidents within the organisation, including those related to clinical trials, advising on Opportunities for Improvement (OFI), CAPAs to be implemented and ensure completion in a timely manner.
Ensure the production of regular reports and information to the Senior Executive Team and the Board, in relation to regulatory compliance and the performance of the Quality Management System.
Working together with the Quality Team to lead, manage and co-ordinate internal and external audits, including regulatory inspections within the company.

You will be a quality assurance expert and have experience of regulations related to clinical services as well as clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical trials research. You will also have experience supporting third party audits and regulatory inspections.

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