Reporting to: Quality Team Lead Location: Location of Work: Office based in Greater Manchester – Bright Building, Manchester Science Park, flexible office/home based arrangements are available. Hours of work: Monday to Friday, 37.5 hours in total, flexible office hours are available. NorthWest EHealth (NWEH) specialise in delivering clinical trials driven by Electronic Health Record (EHR) data. We are the world leaders in this field. By maintaining close relationships with academia and the NHS whilst working alongside global pharmaceutical companies we create new market standards for the evaluation of healthcare interventions. With a new location in Manchester Science Park, NWEH are looking for talented, inventive, and passionate people. This is an excellent opportunity to join a pioneering organisation, helping to redefine how electronic healthcare data is used to benefit patients and facilitate new models of clinical research. Job purpose: · Supporting the Quality Team Lead and Head of Quality and other NWEH teams to ensure activities conducted by NWEH remain compliant with applicable legislation and regulatory requirements. · Support the Quality Team to maintain NWEH’s Quality and Information Security Management System and ensure maintenance of ISO certification and other appropriate industry benchmarks. · Assist with and drive quality improvement initiatives in line with the Business Plan and organisational objectives. · Support the management of Quality Systems, specifically Non-Conformance, Audit, Supplier Qualification and Document management and control. · Manage non-conformances and breaches through to appropriate CAPA closure, including conducting root cause analysis. · Lead and conduct audits in line with internal requirements. · Conduct supplier qualification assessments, and support stakeholders in managing suppliers. · Support to Quality Team and wider organisation to ensure NWEH is inspection ready. · Support to Quality Team in development and maintenance of NWEH’s Quality Management software Q-Pulse. · Support the drive to improve business metrics. Key accountabilities: · Assurance of Quality and Information Security system service delivery to the business, stakeholders and interested parties. Responsibilities: · Lead and conduct Internal auditing and reporting of audit. · Supporting the creation, coordination and review of Standard Operating Procedures (SOPs), reports and other quality related documentation for a range of audiences. · Proactively assist the NWEH Quality team, to ensure NWEH are audit ready against the number of regulatory standards they comply with: GCP, GPP, GDPR, ISO 27001 and ISO 9001. · Manage non-conformance through to closure. Support and train staff in root cause analysis and CAPA. · Support and Complete Supplier Qualification and management processes. · Training and guiding team members on quality processes and best practices. · Maintaining and assisting in managing an up-to-date library of controlled documents on the Q-Pulse Quality Management Software. Including version control and electronic approval of documents. · Build and maintain effective working relationships with key stakeholders, both internally and externally. · Record clear and concise meeting notes and actions for meetings attended including records of external audits. · Build reports from performance data to actively drive improvements. · Facilitating continuous improvement initiatives and promoting a culture of quality throughout the organisation · Support the Quality Team in the production of reports against Quality and Information Security measures for the Head of Quality and wider management groups. · Keeping abreast of new quality standards, technologies, and industry developments to maintain professional expertise · Adhere to NWEH and partner organisation’s policies, processes, provisions, standards and procedures. · Support and manage administration tasks as required. · Participate occasionally in out-of-hours emergency / urgent work cover as required. Person Specification: Essential: · Higher education qualification in Quality Assurance or related subject, or substantial experience in Quality Assurance and Quality System Management (minimum 3 Years). · Experience of ISO 9001 and ISO/IEC 27001 and relevant experience in writing related documentation. · Problem solving abilities with understanding of the importance of implementing effective resolutions. Substantial experience in conducting and driving robust investigations and performing root cause analysis. · Internal Audit qualification and substantive experience of auditing process and systems. · Experienced in supplier qualification and management. · Extensive understanding and experience of Document management and Document control. · Confidence to challenge team members to ensure appropriate and accurate information is available for implementation of appropriate and effective actions. · Proactive approach and ability to multitask within a fast-paced environment, dealing with priorities calmly, flexibly and efficiently. · Ability to work independently with minimal supervision. · High-level of written and verbal communication skills, including the ability to create/update Standard Operating Procedures and other documentation relating to the Quality and Information Security Management system. · Ability to work within a team to enable delivery of wider business objectives. · Demonstration of positive influencing skills. · Good attention to detail and ability to see tasks through to successful completion. · Experience of working with electronic QMS (e.g., Q-Pulse). · The post holder must be a quick learner in relation to relevant internal computer systems used to maintain the QISMS. Desirable: · Experience of working with confidential/sensitive data. · Understanding of Good Clinical Practice requirements and application. · Experience in lean six sigma. Benefits: · 27 day’s annual leave increases with length of service. · Hybrid working policy. · Flexible working hours. · Heath cash plan. · Wellbeing support. · Life assurance. · Stakeholder pension scheme. · Modern offices in Central Manchester. · Positive and supportive environment.