Device Technical Operations Director (Technical Services & Operations)

Recruiter
Viatris
Employment Type
Permanent
Salary
Not disclosed
Viatris logo

1484 McDermott Laboratories Limited

At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.

Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.

Every day, we rise to the challenge to make a difference and here’s how the Device Technical Operations Directorrole will make an impact:

Key responsibilities for this role include:

  • 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 Global Device Development (GDD) 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 Viatris’ 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 or from GDD which are deemed to impact the device/combination product.
  • Leadership of the Global Device Development (GDD) Supplier Management program promoting business continuity through effective management of GDDs suppliers.

The minimum qualifications for this role are:

  • Degree in Life Science, Pharmaceutical Science, Chemical Engineering or Packaging Engineering required with at least 10 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 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.

A t Viatris, we offer competitive salar ies , benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.
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