Head of Quality, Device and Combination Products
Core
Lead global quality strategy and operations for medical devices and combination products, ensuring compliance and lifecycle management from design to supply.
Role type
Senior management quality leader (device/combination products)
Builds
Compliant device and combination product lifecycles for Biogen
Domain
Biotechnology / Medical Devices / Regulatory Quality
Deliverable
client delivery
Required skills
Medical device quality management, regulatory compliance (21 CFR 820, ISO 13485, EU MDR), risk management, supplier management, people management, project management, process validation, CMO supply chain oversight
Preferred skills
Strategic mindset, cross-functional leadership, international matrix navigation
Technologies
None stated
Responsibilities
Develop and implement quality business strategies for device programs; Lead global quality team across design, development, and manufacturing; Manage transfers, deviations, investigations, and CAPAs; Ensure robust QMS execution; Participate in Health Authority audits; Provide quality engineering guidance for GxP activities; Drive continuous improvement of QMS; Represent Quality on cross-functional initiatives; Support internal, external, and regulatory inspections
Seniority
Senior, hands-on management
