Internal Only - Quality Assurance and Regulatory Affairs Manager

at  Cardiff University

Cardiff, Wales, United Kingdom -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate30 Jan, 2025GBP 45163 Annual30 Oct, 2024N/AGood communication skillsNoNo
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Description:

Responsibilities:

JOB PURPOSE

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

DUTIES AND RESPONSIBILITIES

Key Duties

  • 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


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Proficient

1

Cardiff, United Kingdom