Clinical Quality Assurance Manager - IVD

Clinical Professionals Ltd
Closing date
24 Sep 2020

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Quality, QA / QC
Full Time
Contract Type
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Clinical Quality Assurance Manager – IVD
Competitive Salary

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.

Every member of our team is committed to delivering the highest level of service. This translates to offering consistent and exceptional service to each and every candidate we work with. Working in cooperation and partnership our aim is to build trust through consistent delivery, to keep our promises and to exceed expectations.

Our teams are experts in their pharmaceutical markets, both geographically and technically. As we fully understand each of the pharmaceutical sectors we work within, we can be flexible in our approach to matching candidate expectations, finding the right position in the best location. With coverage across nine European Markets via our Multilingual International hub in central London we can offer expert technical knowledge with local understanding.

Contact Us
  • 33 Blagrave Street
  • Reading
  • RG1 1PW
  • GB
  • 0118 959 4990
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