Clinical Quality Assurance Manager – IVD
A leading biotechnology business are looking for an individual to setup and run their Clinical Quality Division based at their Manchester site. The successful candidate will take on responsibility for assuring the quality and compliance of external verification and validation studies. This includes audits of clinical studies as well as quality oversight of internal related activities.
This individual will scope the Clinical Quality Assurance division and establish working practices alongside building a team in the long-term to sit alongside the existing Clinical Affairs and Quality Affairs departments. With clinical trials globally this individual will be required to travel extensively, it is estimated up to 50%.
• Demonstrable, working knowledge of global In vitro Diagnostic Regulations (minimum EU and USA). In addition significant experience of clinical regulations, standards, guidelines and best practice e.g. CFR 812, BIMO, ISO standards, ICH guidelines
• Qualified Auditor
• Experience in performing as a Subject Matter Expert in regulatory inspections and other formal audits e.g. NB audit
• Ability to work cross-functionally
• Excellent knowledge of the in vitro diagnostic industry including product development processes (ISO13485)
• Ability to work independently while exercising good judgement and decision making within defined practices and policies.
• Proficient in reading, analyzing and interpreting scientific and technical information
• Ability to demonstrate and convey high performance, high standards culture
• Skills in MS Office packages (e.g. Excel, Word, Outlook, PowerPoint, Project)
If this sounds like an ideal next step, please apply online or get in touch to discuss further. Any queries can be directed to Kimberley on 07900981267.
- Agency: Clinical Professionals
- Contact: Kimberley Warren
- Reference: JO-2008-453849
- Posted: 26th August 2020
- Expires: 23rd September 2020