Director Technical Operations

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.

• 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.