Quality Team Lead

Salary: £60,000 per year

Quality Team Lead / Quality Manager

(Electronic Health Records used to advance Clinical Trials and Drug Development)

Home based role with access to prestigious offices in the Manchester area circa 1-2 times per month

Base Salary IRO £60,000

Solution — The “data” held within Electronic Health records is analysed and interpreted by software and that is subsequently used as a service that advances drug development. The data is used to direct research and deliver tangible benefits to research-based companies – BIG PHARMA developing new pharmaceutical products / drugs. The solutions afford clinical customers a real time “live” searchable database that provides a wealth of information to assist companies’ developing pioneering lifesaving drugs and devices cutting development time, saving money, and impacting the health of millions globally. Their technology connects electronic health records (EHRs) across primary and secondary care, and enables rapid patient recruitment, reduces clinical trial development time and costs. It also increases responsiveness to patient safety through near real-time monitoring. This technology could be applied to any established health economy across the globe. This has the potential to change the way that clinical trials are conducted in the future by ensuring drugs get to market faster and therefore improving patient outcomes.

Role –

 An opportunity exists for an enthusiastic and organised Quality Team Lead with prior experience in ISO 9001/27001 and GxP to manage the organisational QISMS in line with regulatory requirements and industry best practice. An experienced line manager, you will lead our Quality team activities and will provide quality support to operational delivery, new business projects and quality initiatives. 

You will be joining an innovative and growing organisation who are driving a revolutionary new approach in clinical trials. Our use of data and advanced software helps to improve the way clinical trials are conducted and maximises patient safety.

Responsibilities:

• Management and oversight of the Quality and Information Security Management System 
• Audit
• Operational Delivery
• Relationships / Training

Essential skills:

• Higher education qualification or equivalent experience (3 Years)
• Previous experience in quality team line management roles, ideally within a fast-paced environment
• Excellent understanding of GxP
• Proven track record of maintaining Quality and Information Management systems
• Experience of the production of the documentation to support ISO9001/ ISO27001/Data Protection standards within organisations
• Proven track record of working effectively with project teams to establish and deliver quality excellence.
• Experience of internal auditing and hosting external audits
• Problem solving and ability to ability to explain complex technical concepts to a wide range of audiences
• High-level of written and verbal communication skills
• Experienced in use of quality tools and techniques
• Confident communicator and trainer – able to work within a cross-functional team to enable delivery of wider business objectives.
• Organisational skills and experience of creating and implementing plans to meet standards set by regulatory bodies
• Proven track record of being able to prioritise work and work to demanding deadlines
• Good attention to detail and ability to see tasks through to successful completion.
• Self-development and motivation
• Adaptability/ flexibility/Collaborative

Desirable skills: 

• Experience of working with confidential/sensitive data
• Internal Auditor certification
• Previous experience of working across teams, sectors and/or different industries
• Experience of successful assessment against NHS Digital DSPT
• Understanding of clinical governance/data handling/ safety monitoring and reporting 
• Experience of implementing Quality and Information Management systems
• Good understanding of information governance guidelines in a clinical setting 
• Understanding of system validation requirements and computer system validation
• Exposure to working in a software development environment
• Experience of working with JIRA/Q-Pulse.

Benefits: 

Competitive Salary

27 day’s annual leave

Flexible working hours

The ability to work from home

Modern offices in Central Manchester

Positive and supportive environment

Access to training resources

Exposure to different industries

Access to collaborative workspace

Stakeholder Pension

Childcare Vouchers