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.