Quality Associate Director - Steriles Device Development

Job Ref: J32064
Sector: Science
Sub-sectors: Biotech/Life Sciences, Medical Devices
Job Type: Permanent
Date Added: 12 June 2019
  • Runcorn, Cheshire, England, UK Runcorn Cheshire UK WA7 3FA
  • Competitive
  • Rachael Usher
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Quality Associate Director - Steriles Device Development

Runcorn, North West (+occasional travel)


Full-time (flexibility offered)

Highly competitive salary + benefits package

SRG are working with a Global Pharmaceutical Organisation who are looking for a highly talented scientific leader to ensure their Steriles Device Development teams follow compliance with the Quality Management System (QMS). You will be primarily based at the Runcorn site and will oversee the development and implementation of GMP policies for the R&D multi-sites across Europe.

As the Associate Director, your day-day tasks will include:

  • Assuring that the multi-site activities maintain compliance with QMS and applicable regulatory requirements with focus on ISO 13485, FDA and EU Medical Device Regulation (MDR) as applicable
  • Generate and maintain design history files and approve design control activities
  • Apply subject matter expert functional knowledge of the regulations, device delivery system technologies, and existing quality methodologies to solve complex device design development and compliance issues
  • Manage a team of Senior Quality Engineers and represent organisation at Global meetings
  • Provide training and technical expertise to junior staff members when necessary
  • Lead audit preparations including reviewing CAPAs, change controls and design documentation review with the R&D QA team
  • Communicate with senior executive management on device development status.

You will have:

  • Ideally a scientific background and extensive experience within a Quality environment (GMP exposure is essential)
  • Provide expertise in QMS design, ideally Trackwise, with relation to steriles devices (such as injectables, nasal spray, transdermal patches)
  • Have participated/lead audit investigations and liased with ISO, FDA and/or EU regulatory bodies
  • Direct line management experience/collaboration with CMOs or third parties
  • Excellent communication skills.

Please contact Rachael Usher (Rachael.usher@srg.co.uk) if you have any questions regarding this position: or alternatively, you can call Rachael at 0161 868 2250.

12/07/2019 08:46:53