Head of Quality Assurance (SP36HM164)
RoleAll Other Remote
Cmed, an Aixial Group company, 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, and cell therapy, but also as specialist functional service provider. Cmed is also 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 DCTs.
We are currently looking for an enthusiastic and talented Head of Quality Assurance for our CRO Business Unit.
You will be responsible for developing and delivering a Quality Assurance Strategy in line with the objectives of the Aixial Group as well as the CRO Business Unit; managing and developing an integrated Quality Management System; verifying that Operations meet the relevant internal standards, good practices, and regulatory requirements with regard to policy, procedures and systems; supporting internal and client audits; and acting as a consultant on all company quality issues. A key aspect of the role will be to support the integration of several entities in the CRO Business Unit.
- 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 internal, 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
- Collaborate with Global Compliance in regards to Computer Systems Validation support.
- 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
- Company integration experience would be a benefit
What we offer:
- The opportunity to be part of a friendly, supportive team and work with exciting technologies
- Remote location
- 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