Quality R&D Lead

We are looking for a Quality R&D Lead to join our Quality R&D team in Milan, supporting our Drug Delivery Systems (DDS) Business Unit.

In this role, you will act as the Quality reference within product development projects, ensuring compliance with the Quality Management System (QMS) and applicable standards, leading design reviews and approving key design control deliverables.

Key accountabilities

• Act as Quality Lead in product development projects, ensuring design development and transfer to Operations follow Design Control principles.
• Support the Design Team as quality and technical reference in key decisions.
• Lead quality activities across product and process development, including design planning, inputs, outputs, verification, validation and design transfer.
• Review and approve Design Control documentation, DHF and Risk Management deliverables.
• Act as Process Owner for Design & Development procedures, templates and tools.
• Ensure correct application of procedures through training and continuous support to R&D teams.
• Lead change impact and risk assessments, supporting change approval and lifecycle change control.
• Review and approve Risk Management File deliverables.
• Collaborate with internal and external stakeholders to promote a strong and modern quality mindset.

Qualifications

• 4-7 years’ experience in Quality Assurance R&D within Medical Device / Pharma / regulated environments.
• Strong knowledge of Design Control, Change Control and Risk Management.
• Familiarity with QMS and applicable standards and regulations.
• Strong communication skills and ability to work cross-functionally.