Quality Manager

Salary: £48,000 – £54,000 per year

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 £ Competitve

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 –

• To support the Quality Team Lead and Head of Quality and other stakeholder teams to ensure activities conducted remains compliant with applicable legislation and regulatory requirements
• To provide quality support to the clinical project delivery teams to ensure that all clinical operations are compliant with appropriate GxP regulations and are in a state of audit readiness for external inspections.
• To manage quality improvement initiatives in line with the Business Plan and organisational objectives
• To work with the Quality Team Lead to maintain Quality and Information Security Management System and ensure maintenance of ISO certification and other appropriate industry benchmarks. 
• Support the Quality Team Lead to manage non-conformances and breaches through to appropriate CAPA closure, including conducting root cause analysis.

Responsibilities:

Management of activities to support the maintenance of the Quality and Information Security Management System 

Supporting the design of the quality management system to assist delivery of clinical activities during ongoing clinical trials

Internal auditing of working practices against Standard Operating Procedures, standards, and regulatory requirements

Working with the Quality Team Lead to execute the internal audit plans

Responsible for technical writing and reviewing documents such as work instructions, user documentation, and guidance documents

Working with Quality Team Lead and wider teams to support maintenance of the required quality and information security standards for activities in all ongoing projects.

Support Quality Team Lead and wider organisation to monitor, audit and report on service performance and security in order to identify and address areas of risk and ensure compliance with service level expectations.

Deputise for Quality Team Lead at regular IG steering group meetings, Quality and Validation Group meetings and other appropriate forums. 

Support to validation activities in conjunction with Quality Team Lead and wider technical teams

Support the Quality Team lead in the production of reports against Quality and Information Security measures for the Head of Quality and wider management groups 

Support the Quality Team Lead to solve critical technical and delivery challenges

Support to the development and delivery of training materials to wider organisation to support quality and information security initiatives

Support effective working relationships between the Quality Team with key stakeholders, both internally and externally (e.g. IG Leads, Auditors, Regulators, Suppliers)

Adhere to internal and partner organisation’s policies, processes, provisions, deployment and maintenance standards and procedures

Participation as an auditee in audits of performance, quality, regulatory and operational effectiveness

Support to routine administration tasks as required

Participate in occasional out-of-hours emergency / urgent work cover as required

Essential skills:

Higher education qualification or equivalent experience (5 Years)

Experience in quality management roles (3 Years)

Excellent knowledge and understanding of ICH/GCP requirements 

Experience of working with the life science industry in a quality management role

Proven track record of maintaining Quality and Information Management systems

Problem solving and ability to ability to explain complex technical concepts to a wide range of audiences

Proactive approach and ability to multitask within a fast-paced environment

High-level of written and verbal communication skills

Understanding of preparing and maintaining team activities to meet standards set by regulatory bodies

Internal auditing experience

Proven track record of making quality improvements in a complex organisation

Confident communicator and able to work within a team to enable delivery of wider business objectives

Desirable skills: 

Experience of working with confidential/sensitive data

Exposure to working in a software development environment

Internal Auditor qualification

Experience of working with 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