Posted 11 months ago  

Global Head of Quality Assurance

Posted 11 months ago - 139 views - 17 Applied

Job Description

Cmed occupies a unique position in the clinical research industry, not only as a CRO expert in the operational delivery of clinical trials in complex disease areas including oncology, immuno-oncology, and cell therapy, but also as a developer of its own cutting-edge technologies for managing clinical data. encapsia® is our ultramodern, innovative and game changing clinical data system for EDC, eSource and much more. We are currently looking for an enthusiastic and talented Global Head of Quality Assurance to be home-based anywhere in the UK or office-based in Horsham, West Sussex. 

As a Global Head of Quality Assurance, you will be responsible for developing and delivering a Quality Assurance Strategy in line with the objectives of the Board of Directors;  managing an appropriate Quality Management System;  verifying that Cmed operations meets the relevant internal standards, good practices and regulatory requirements with regard to policy, procedures and systems; and acting as a consultant on all company quality issues.

Key responsibilities:

  • Establish, implement and maintain a global Quality Management System.
  • Promote a pragmatic, proactive and supportive culture within the company environment, which maintains an appropriate level of regulatory compliance whilst facilitating the achievement of project deliverables & timelines
  • Lead the definition & documentation of appropriate standards of quality. Facilitate implementation by coaching, mentoring & leading personnel
  • Identify process gaps and/or quality deficiencies in Cmed global activities, proposing opportunities for improvement & raising awareness of unmet Cmed educational needs.
  • Lead Sponsor Company Audits and Regulatory Authority Inspections.
  • Communicate & clarify audit requirements & process quality control steps by preparing an audit strategy & maintaining an audit and/or quality review plan
  • Providing Computer Systems Validation support assuring software used and developed by Cmed follows the principles of the embedded quality management system
  • Pro-actively contribute to global management team discussions by providing quality/compliance management & consultancy on international projects & overall business operations.
  • Verify that documented working practices reflect global regulatory requirements. Facilitate the introduction of appropriate streamlined procedures, which remove areas of non-added value activity, aid communication & facilitate the overall development process
  • Undertake facility, system and project reviews and report any observed issues to Cmed Senior Management.
  • Ensure that a system for collating, monitoring, reporting and closing corrective and preventive action items is established and maintained.

Qualifications and attributes:

  • Experience in a Quality Function within a Regulated environment with a proven track record of delivery
  • Experience of coordinating Global Teams
  • Excellent and proven knowledge of operating in a GCP environment, with a mind set to challenge the status quo and innovate processes
  • Line management experience essential
  • Strong Leader who can think strategically, has strong communication and influencing skills, and is willing to challenge the Status Quo and drive change

What we offer:

  • The opportunity to be part of a friendly, supportive team and work with exciting technologies
  • Remote location, anywhere in the UK or office-based in Horsham, West Sussex
  • Competitive salary and benefits

For more information on Cmed Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page (https://www.cmedresearch.com/careers/).

Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application