Internal Only - Quality Assurance and Regulatory Affairs Manager

Internal Applicants Only - Quality Assurance and Regulatory Affairs Manager Centre for Trials Research (CTR) College of Biomedical & Life Sciences The Centre for Trials Research at Cardiff University is a large, multinational community of researchers, professional services staff and students from a diverse range of backgrounds. We tackle the big diseases and health concerns of our time by forming partnerships with researchers and building lasting relationships with the public. Find out more about the Centre and working with us here. You will support the Centre with Quality Assurance and Regulatory Affairs (QA & RA) work providing advice, guidance and training and developing and leading on projects within QA & RA. You will undertake review of clinical trial documentation (e.g. protocols, case report forms, database specifications and user acceptance testing) and will collaborate with others to make recommendations for improvements on established processes and procedures. You will undertake administrative duties including use and administration of Q-Pulse, the Centre's Quality Management system and will provide training to Centre staff on its use. You will assist the Head of QA & RA with oversight of mandatory learning and development activities., Deliver for the Centre high quality Quality Assurance and Regulatory Affairs' (QA & RA) work, carrying out supporting work, providing advice, guidance and training and developing and leading specialist areas within Quality Assurance and Regulatory Affairs,

• Provide professional advice and guidance on Quality Assurance and Regulatory Affairs processes and procedures to internal and external customers, using judgement and creativity to suggest the most appropriate course of action where appropriate, and ensuring complex and conceptual issues are understood
• Take responsibility for Quality Assurance and Regulatory Affairs for individual projects, solving issues independently when they arise and where they fall within set role objectives
• Develop and lead on areas of specialist knowledge within Quality Assurance and Regulatory Affairs
• Investigate and analyse specific issues within Quality Assurance and Regulatory Affairs, creating recommendation reports, supported by advances in regulation or recognised good practice.
• Ensure that the provision of Quality Assurance and Regulatory Affairs are delivered to the Centre, proactively changing the delivery according to requirements
• Establish working relationships with key contacts, developing appropriate communication links with the University's Schools/Directorates and outside bodies as required
• Create specific working groups from colleagues across the University to achieve Centre objectives
• Plan and deliver specific small scale projects, co-ordinating and supervising project teams created as needed
• Develop and deliver training within Quality Assurance and Regulatory Affairs
• Undertake a variety of administrative duties to support the Centre
• Instruct and guide other employees across the University within Quality Assurance and Regulatory Affairs Ensure that work is undertaken and documented in a regulatory compliant way and be prepared for regular audits and inspections, as well as contributing to the development of the Quality management system for the area of Quality Assurance and Regulatory Affairs
General Duties
• Ensure that an understanding of the importance of confidentiality is applied when undertaking all duties
• Abide by University policies on Health and Safety and Equality and Diversity
• Perform other duties occasionally which are not included above, but which will be consistent with the role
  
  Candidates should hold a degree/NVQ4 or equivalent professional membership or have experience of working in a clinical trials or research environment with demonstrable Quality Assurance or regulatory affairs experience. Candidates should have the ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people and be able to solve expansive problems using initiative and creativity. Experience of undertaking audits or quality reviews of trials documentation would be advantageous. Previous experience of a Regulatory Affairs Role would also be advantageous.
With a culture of continuous professional and career development the Centre has an excellent track record of helping people develop in their areas of interest, with many progressing within the Centre itself, the wider University or further afield., Qualifications and Education 1. Degree/NVQ 4 or equivalent Professional membership/experience Knowledge, Skills and Experience 2. Substantial experience of working within Quality Assurance and Regulatory Affairs 3. Able to demonstrate professional knowledge within Quality Assurance and Regulatory Affairs to give advice and guidance to internal and external customers 4. Proven experience in developing new systems and processes Customer Service, Communication and Team Working 5. Ability to communicate conceptually detailed and complex information effectively and professionally with a wide range of people 6. Evidence of ability to explore customers' needs and adapt the service accordingly to ensure a quality service is delivered 7. Proven ability to develop networks in order to contribute to long term developments Planning, Analysis and Problem solving 8. Evidence of ability to solve expansive problems using initiative and creativity; identify and propose both practical and innovative solutions 9. Evidence of demonstrable knowledge of key advances Quality Assurance and Regulatory Affairs 10. Evidence of ability to undertake and deliver specific projects and supervise short term project teams Desirable Criteria 11. Experience of working in industry 12. Postgraduate/Professional qualification 13. Experience of working in a trials environment 14. Fluency in Welsh, written and oral

Cardiff University is committed to supporting and promoting equality and diversity and to creating an inclusive working environment. We believe this can be achieved through attracting, developing, and retaining a diverse range of staff from many different backgrounds. We therefore welcome applicants from all sections of the community regardless of sex, ethnicity, disability, sexual orientation, trans identity, relationship status, religion or belief, caring responsibilities, or age. In supporting our employees to achieve a balance between their work and their personal lives, we will also consider proposals for flexible working or job share arrangements., Applications may be submitted in Welsh, and an application submitted in Welsh will not be treated less favourably than an application submitted in English.

This post is part-time (14 hours per week), fixed-term based at Heath Park and is available from 1st December 2024 until 30th April 2025 The majority of roles at Cardiff University are currently operating under "blended working" arrangements, with staff having the flexibility to work partly from home and partly from the University campus depending on specific business requirements. Discussions around these arrangements can take place after the successful candidate has been appointed. Salary: £40,247- £45,163 per annum, pro rata (Grade 6). Appointments to roles at Cardiff University are usually made at bottom of scale unless in exceptional circumstances. Cardiff University offers many excellent benefits, including 45 days annual leave (incl. bank holidays), local pension scheme, a cycle to work scheme and other travel initiatives, annual increments within the pay scale, and more. It's an exciting and vibrant place to work with many different challenges and is a proud Living Wage supporter. Business needs will require some degree of office-based working but the balance of time can be spent in the office or remotely (subject to agreement with the line manager).