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Make your application after reading the following skill and qualification requirements for this position.
Galway
are seeking a
Senior Process Development & Operations Manager
to play a pivotal role in advancing and scaling its Class III product portfolio. This position will lead
process development and operational
readiness, supporting pilot manufacturing and future commercialisation.
Key Responsibilities
Lead end-to-end process development from clinical stage through scale-up to commercial readiness
Oversee and optimise pilot production lines, partnering with external manufacturing providers
Drive operational excellence and continuous improvement across engineering and manufacturing activities
Collaborate closely with R&D to ensure effective transfer from development into manufacturing (NPI)
Develop scalable, compliant processes aligned with regulatory standards (FDA, ISO 13485)
Lead, mentor, and grow a high-performing team
Contribute to strategic planning for manufacturing scale-up and long-term operations
Key Requirements
Minimum 10 years’ experience in the medical device industry (essential), ideally with Class III products
Strong background across manufacturing, operations and process development in regulated xcfaprz environments
Proven experience supporting products from clinical stage through scale-up
Demonstrated expertise in process optimisation and new product introduction
Prior people management and leadership experience
Experience working within or alongside multinational organisations highly desirable
Strong technical, analytical and cross‑functional leadership capabilities
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Sprachkenntnisse
- English
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