Our client, a fast-growing medical device company, is seeking a Head of Clinical Quality Assurance to be based out of its Zug office.
You will be accountable for ensuring the quality standards of clinical studies are maintained and meet the agreed requirements.
Head of Clinical Quality Assurance - Zug, Switzerland
You need background and theoretical knowledge on the associated regulations related to clinical trials and will manage a growing team covering QMS and Auditing.
Responsibilities of the Head of Clinical Quality Assurance will include:
- Creating and defining relevant SOPs in relation to the subject area – perform GAP analysis to update standards and regulations
- Display commercial awareness of regulatory changes in the quality and clinical trial/study area
- Planning and oversight of audits and results
- Manage CAPA and quality improvement projects
- Integrate and work with other areas of the Quality and Operations department to bring improvements and development to the quality processes
- Guide a team through quality improvements in association with the company’s ongoing growth
- Develop and improve the Quality Management System
- Create and execute quality agreements in relation to clinical studies and investigations
As it continues to experience growth, my client is offering an excellent opportunity for a proven Head of Clinical Quality Assurance professional.
Ideal requirements and qualifications include:
- Educated to degree or equivalent level
- Minimum 8 years’ experience within Quality and/or Clinical Study environment
- Ability to work to relevant regulations in pharmaceutical or medical device industries – knowledge of MDR, ISO 14155 or ISO 13485 would be essential
- GMP background and strong knowledge of medical device regulations
- Six Sigma qualification or demonstrable ability to implement Lean methodology would be desirable
- Able to work in a fast-paced and changing environment
- Willing to work in an international environment and travel up to 40% when required
- Fluency in English - any other language would be beneficial
If you are interested in applying for this Head of Clinical Quality Assurance role, please register your interest using the link below. Alternatively, please send your CV to email@example.com or for a confidential conversation please call Neil Cope in our Zug office on +41 41 508 70 07
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