Freeman Hospital ยท 5 hours ago
Quality Assurance Manager
Carthage, MO
Full-time
Onsite
Senior LevelNewcastle Hospitals NHS Foundation Trust is one of the busiest and largest NHS hospital trusts in the country, and they are seeking a Quality Assurance Manager for the Clinical Research Directorate. The role involves overseeing the Quality Management System and audit plan, supporting teams with regulatory affairs, and leading a quality assurance team in compliance with Good Clinical Practice and other regulations.
Hospital & Health Care
Responsibilities
Ensure that the annual audit plan is approved and completed
Provide data in relation to key audit findings and solutions to the Senior Management Team
Ensure that the quality policy and manual are maintained and fir-for-purpose
Provide support and advice for processes and standard operating procedures
Support the NJRO Lead with key decision making and strategy
Provide line manager for a mixed team of Newcastle Hospitals and Newcastle University staff
Report to appropriate committees and boards
Provide key advice and support for regulatory inspections
Be a key player in Corrective and Preventative planning
Ensure risk assessments are completed for particular regulatory and governance matters
Work closely with external stakeholders to ensure quality across partners within the North East and North Cumbria
Support the Directorates approach to digitalisation
Ensuring all processes contributing to the performance of any trials are conducted in accordance with ICH-GCP guidelines, relevant SOPs and other regulations
Developing a Quality Management System, the focus of which is to develop, perform and manage quality assurance-relates activities from policy level through to coordinating appropriate SOP development, ensuring compliance via undertaking a risk-adaptive audit programme
Ensure that audit results are formally and consistently recorded and reported and that corrective/preventive actions have been requested and documented effectively
Training of JRO staff and others as required (either directly or indirectly) regarding GCP, QA and regulatory audits
Ensure that Sponsor and Regulatory audits are effectively executed and provide support and direction during the hosting of such audits as necessary, assisting the Research Governance Manager as required
Qualification
Required
Awareness of fundamental national and local NHS and R&D policies
Evidence of relevant continuous professional development
Excellent interpersonal and communication skills
Organisation and planning skills
Leadership and management skills
Negotiation, persuasion and problem-solving skills
Project management skills and knowledge
Research and audit skills
Broad IT skills
Service improvement/change management skills
Well-developed report writing and analytical and presentation skills
Extensive theoretical and practical experience of research governance, audit and policy development in a range of settings to Masters level or equivalent
Proven experience in a GCP environment and/or quality setting, including policy developments
Experience of preparing for external inspection
Experience of monitoring compliance with national risk management/quality standards
Ability to work strategically
Masters level qualification or equivalent qualification or equivalent experience
Preferred
Experience in a corporate leadership role
Extensive of conducting pharmacovigilance audits
Company
Freeman Hospital
Freeman Hospital, Newcastle, UK
Carthage, Missouri, US
10001+ employees
Funding
Current Stage
Late StageCompany data provided by crunchbase