Senior Manager, Global Device Quality
Core
Provide global leadership to establish, maintain, and implement Viatris' Global Quality Standards for medical devices and combination products, ensuring compliance with international regulatory requirements.
Role type
Senior Manager, Global Device Quality
Builds
Global Quality Management Systems (QMS) and compliant practices for medical devices and combination products
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global cGMP regulations expertise, Medical device regulatory requirements knowledge, Quality and compliance function leadership, Cross-functional team management, Regulatory authority engagement, Post-market surveillance management, SOP creation and review
Preferred skills
Experience with EU MDR and FDA regulations, Third-party supplier management, Performance management and team development
Technologies
Microsoft Office (Word, Excel, Outlook)
Responsibilities
Lead continuous improvements in quality system practices, Align on corporate-wide Quality initiatives and KPIs, Serve as subject matter expert for QMS and Conformity Assessments, Evaluate and implement standardized compliant practices, Participate in global inspection preparedness and audit responses, Interact with Regulatory Authorities and lead submissions, Ensure compliance with post-market surveillance and vigilance requirements, Create and improve global SOPs and policies
Seniority
Senior, hands-on IC with people management responsibilities