Global Quality Systems & Compliance Leader

BD; Sparks Corner (MD); On-site; USD 150,000 - 239,000; Full time

Benefits offered by this job

Total Rewards program

Competitive compensation & benefits

Job summary

BD in Sparks, MD is seeking a Sr. Manager Quality Systems Compliance to lead regulatory and quality programs across the global organization. You will drive readiness, governance, and reporting of Q&R risks to executive forums.

This role requires partnering with cross-functional teams and delivering improvements in a highly regulated environment. As GPO, you will oversee strategies and tools for effective execution, foster change management, and use SharePoint, PowerBI, and Excel to visualize

Qualifications

• B.S./B.A. in engineering or technical field.
• 8+ years in a regulated field (medical devices, IVDs, pharmaceuticals, or biologics).
• Experience with Quality/Regulatory/Compliance teams and/or improvement operations.
• Process excellence certification (SSGB, lean, etc.) preferred.

Responsibilities

• Maintains knowledge of regulatory requirements and trends and communicates insights for improvement.
• Leads development of strategies and tools for effective execution and monitoring as GPO.
• Supports global initiatives and change management planning.
• Communicates/escalates issues to senior leadership via escalation process.
• Coordinates data collection, analysis, reporting, and global site list maintenance for Q&R scans.
• Participates in cross-functional initiatives to support Quality Systems.

Skills

Regulatory compliance

Quality systems

Project management

Cross-functional collaboration

PowerBI

Excel

Education

B.S. or B.A. in engineering or technical field

Tools

SharePoint

Excel

PowerBI

Visio

PowerPoint

Job description

BD in Sparks, MD is seeking a Sr. Manager Quality Systems Compliance to lead regulatory and quality programs across the global organization. You will drive readiness, governance, and reporting of Q&R risks to executive forums.

This role requires partnering with cross-functional teams and delivering improvements in a highly regulated environment. As GPO, you will oversee strategies and tools for effective execution, foster change management, and use SharePoint, PowerBI, and Excel to visualize