Global Quality & Regulatory Compliance Leader

BD; Maryland; On-site; USD 150,000 - 239,000; Full time

Job summary

Waters is hiring for a Sr. Manager Quality Systems Compliance. This role ensures ongoing readiness by managing regulatory and standards processes, promoting continuous improvement, and providing governance visibility for Q&R risks across Waters.

The GPO for Regulation & Standards Compliance leads cross-functional initiatives and partners with leadership to implement new and revised regulations globally, driving quality across the organization.

Qualifications

• Bachelor's degree in engineering or technical field.
• 8+ years in a regulated field (medical devices, IVDs, pharma) with Quality/Regulatory/Compliance experience.
• Process excellence certification (SSGB, lean, etc.) preferred.
• Strong influencing, communication and project management skills in a global matrix environment.

Responsibilities

• Maintains knowledge of regulatory requirements and interpretations, proactively monitors Q&R compliance trends and communicates insights across Waters.
• As GPO, partners with stakeholders to develop strategies and tools for effective execution and monitoring.
• Supports Leadership Team in designing and implementing global initiatives and change management plans with timely escalation to senior leadership of Q&R risks.
• Works with units, regions and sites to ensure Q&R Compliance Scan activities are completed with data collection, visualization, analysis and reporting.
• Participates in key initiatives and projects to support the Quality Systems team.

Skills

Analytical skills

Problem solving

Communication

Leadership

Education

Bachelor's degree in engineering or technical field

Tools

SharePoint

PowerBI

Excel

Word

PowerPoint

Visio

Job description

Waters is hiring for a Sr. Manager Quality Systems Compliance. This role ensures ongoing readiness by managing regulatory and standards processes, promoting continuous improvement, and providing governance visibility for Q&R risks across Waters.

The GPO for Regulation & Standards Compliance leads cross-functional initiatives and partners with leadership to implement new and revised regulations globally, driving quality across the organization.