Sr. Manager Quality Systems Compliance
Core
Establishing ongoing state of readiness by ensuring visibility of compliance risks and governing regulatory and standards management processes for the organization.
Role type
Senior Manager, Quality Systems Compliance (Global Process Owner)
Builds
Global regulatory and standards management processes, compliance risk visibility, and governance frameworks
Domain
Life Sciences / Medical Devices / IVDs / Pharmaceuticals
Deliverable
dashboards & analysis
Required skills
Regulatory requirements knowledge, Quality/Regulatory/Compliance operations management, Process excellence (SSGB, lean), Strategic planning, Change management, Data analysis and reporting, Cross-functional leadership
Preferred skills
Process excellence certification (SSGB, lean), Experience in regulated fields (medical devices, IVDs, pharmaceuticals, biologics)
Technologies
SharePoint, PowerBI, Excel, Word, PowerPoint, Visio
Responsibilities
Monitor emerging Q&R compliance trends and communicate external insights; Partner with stakeholders to develop strategies and tools for execution and monitoring; Design and implement global initiatives and change management plans; Lead communication/escalation of Q&R Compliance risks to senior leadership; Ensure Q&R Compliance Scan activities are accomplished across business units and regions; Review data collection methodology to drive efficiency
Seniority
Senior, hands-on IC with strategic oversight
