Head of Production – Omnisol (m/f/d)

About the role

Vivalyx is seeking a Head of Production – Omnisol to build and lead the production setup that ensures a reliable, quality‑assured supply of Omnisol across Europe. You will act as the on‑site interface with our external manufacturer while shaping a scaled production model for future growth.

Key responsibilities

• Manage day‑to‑day production at the external manufacturing site, ensuring smooth small‑scale runs and compliance with quality standards.
• Design and implement a scaled‑up production process, including supplier qualification, facility build‑up, and validation.
• Coordinate with regulatory and quality teams to align production activities with ISO standards, the European Pharmacopoeia, and EU MDR requirements.
• Develop and oversee sales‑ and logistics‑supporting processes to guarantee timely delivery to patients and physicians.
• Lead cross‑functional teams and external partners to achieve operational readiness for expanding market demand.

Required profile

• Significant experience in production, operations, or scale‑up within a regulated environment.
• Proven ability to work in a setting where structures are still being built and to take ownership of strategic and hands‑on tasks.
• Strong strategic thinking combined with disciplined implementation skills.
• Comfort navigating complex regulatory landscapes and collaborating with quality and compliance functions.

Required skills

• Process design and production scale‑up
• Validation and qualification of facilities and suppliers
• Compliance with ISO standards and European Pharmacopoeia
• Knowledge of EU Medical Device Regulation (MDR)

What we offer

• Opportunity to work on groundbreaking medical technology with meaningful impact.
• Dynamic, highly skilled team and flat hierarchical structure.
• Flexible mobile working conditions.
• Professional development, career growth, and an attractive employee participation program.