Head of Quality Assurance
Location
Ellesmere Port, Cheshire | United Kingdom
Job description
EMS Healthcare are the UK’s largest mobile clinical research partner, and we have supported over 50 NHS Trusts, Health Boards and private providers in delivering mobile capacity across the healthcare landscape.
Working at EMS Healthcare is varied and rewarding, and every project we are part of has one thing in common, it’s about improving health outcomes for everyone.
From a partner in the delivery of the GRAIL NHS-Galleri trial - the world’s largest trial of a blood test that can detect more than 50 types of cancer - to providing clinical teams with additional capacity whenever and wherever they need it. We work alongside a wide spectrum of healthcare partners and our dedicated teams are committed to making a difference to people’s lives.
Requirements
We are looking for an experienced Quality and Compliance leader to oversee the operational and clinical quality and compliance across all of EMS Healthcare. Working with the Quality team, you will provide organisational support to ensure that EMS Healthcare are meeting their regulatory requirements and to assist in highlighting early areas that need support. In addition, you will provide support across all services in regard to clinical and non-clinical audits/outcomes as well as for clinical trials whilst constantly working on ways to improve. The Head of Quality Assurance will work with the EMS Executive Team to promote across the whole organisation an awareness of and commitment to the quality standards and objectives required by the business, through effective motivation, communication and training.
Working closely with the Chief Operating Officer (COO), the role will have direct interaction with various departments, multiple areas and senior managers across the business. The Head of Quality Assurance will work directly with the COO and support continual improvement projects. The Head of Quality Assurance will directly line manage the Compliance and Quality Manager and oversee the Quality Team.
To be successful in this role, applicants need to have the following essential skills and experience:
- Substantial proven experience of taking a Quality Assurance leadership role within a clinical environment, clinical trials either in academia, contract research or the pharmaceutical industry.
- Extensive experience of Quality Systems.
- A scientific degree or equivalent experience.
- In-depth working knowledge 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.
- Experience in supporting third party audits and regulatory inspections.
- Proven leadership expertise, with a pragmatic approach.
MAIN PURPOSE OF THE ROLE:
Key Accountabilities:
- 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 an EMS 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 EMS 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 EMS, 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 systems are in place to support selection and approval of new suppliers of products, materials, and services.
- Ensure the production of regular reports and information to the Senior Executive Team and EMS Board, in relation to regulatory compliance and the performance of the Quality Management System.
- To attend and contribute to operational meetings and support events as required.
- Working together with the Quality Team to lead, manage and co-ordinate internal and external audits, including regulatory inspections within EMS Healthcare
Benefits
We are a people-first organisation and we're proud to do what is right and sustainable for our people, community, and environment.
Our colleagues are our champions, and we have a colleague committee that drives progress for us as a business. We have designated champions in areas including community, environment, mental health, diversity, and inclusion.
From volunteering days helping our local community, to fundraising events supporting our charity of the year (chosen by our employee of the year), we work together to create meaningful change.
- 94% of our colleagues agree that EMS Healthcare has a positive impact on society
- 90% of our colleagues say EMS Healthcare is a great place to work
- With 1 mental health first aider for every 10 colleagues and activities throughout the year, wherever our employees are based, we make time to promote positive mental health
Benefits
We are a family-first team, which is why our hours and days are flexible. We know life can be different weekly, so we trust you to work your hours, in your own way.
This role is hybrid - with a minimum of 3 days per week in our Ellesmere Port office.
This flexibility is matched by opportunities to progress. Promotions are in your hands, and we work together with our employees to make sure their careers are on their right path and that we’re helping them get to their goals via training and opportunities.
You work hard for us; we work hard for you. It is that simple. And we know, it sounds too good to be true (we hear that a lot). But trust us, this could be the best decision you make.
- Flexible hours and days negotiable (up to FTE of 39.5)
- Bank holidays, plus 25 days annual leave, increasing to 28 after 5 years
- 1 Occasion Day each year; this could be your child’s first day of school, their nativity play, or your own birthday – the choice is yours!
- Opportunity to buy 3 additional annual leave days
- Enhanced maternity and paternity leave
- A health scheme funded by EMS Healthcare, where you can claim back health treatments including dental, massages and physiotherapy
- From leisure to home appliances and clothes - everyone gets access to personalised benefits, rewards, and discounts via a Benefits Hub
Job tags
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