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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Director Technical Operations


Reference:JC030322 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Technical Project Manager

Our client a global healthcare company currently seeks a Director of Technical Operations to join their team. Role is part of a Global R&D Group working on a wide portfolio of products. Hybrid working model avaialble


Role/Responsibilities:

  • Leadership of the Device Technical Services & Operations team responsible for the technical support and transfer of manufacturing and associated controls of Devices and Combination Products from the Group in R&D to Commercial Manufacturing Sites to ensure successful launch and ongoing commercial manufacture, including with consideration of device design control (ISO 13485 and 21 CFR 820).
  • Forming strategic technical partnerships with affiliate manufacturing sites and Contract Manufacturing Organisations to influence and enable the development, manufacture and on-market support of devices and combination products across a variety of technology platforms.
  • Strategic leadership of cross-functional teams to enable technology transfer, validation, methods transfer, troubleshooting, investigations, CAPAs, change controls, deviations etc.
  • Ownership for the generation of Device Technical Transfer Plans and Reports outlining the transfer of all required deliverables including equipment requirements, manufacturing controls and control strategy including test specifications.
  • Providing technical leadership to the technical operations team for the troubleshooting of all device related issues/investigations through technical transfer, launch and commercialization across the Company.
  • Responsible for driving knowledge transfer from the global device development group to commercial sites including training on relevant technical transfer activities.
  • Leadership of the technical team who provide market support at supplier/manufacturing sites for device-related complaints, supporting the resolution of device-related investigations to root cause and the establishment of appropriate corrective actions.
  • Provide oversight for Management Review and approval of all change controls issued from the commercial site post transfer
  • Leadership of the Supplier Management program promoting business continuity through effective management of suppliers.



Skills/Experience:



  • Degree in Life Science, Pharmaceutical Science, Chemical Engineering or Packaging Engineering required with at least 12 years relevant experience in the pharmaceutical industry or related field.
  • Or Master’s Degree with at least 10 years relevant experience as noted above
  • Previous experience of Technical Transfer and Technical Support in high volume GMP manufacturing environment with direct experience in R&D and/or technical operations/technical support.
  • At least 5 years leadership experience, including management in a matrix environment.
  • A working knowledge of ISO 13485 & FDA 21 CFR Part 820 Design Control requirements would be an advantage.
  • Excellent planning and communication skills and ability to operate across global teams to drive effective engagement with key stakeholders internally and externally.
  • Excellent interpersonal skills including active listening, effective meeting management, negotiation, and influencing.
  • Willingness to travel as necessary between the Global Device Development Teams & suppliers.
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322