Global Quality Systems & Compliance Leader

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

Job summary

BD is a global medical technology leader, seeking a Senior Manager of Quality Systems Compliance to drive regulatory governance and continuous improvement across Waters’ operations. This role focuses on visibility of compliance risks, metrics, and governance across executive forums.

You will partner with cross-functional leadership to implement regulatory programs, monitor compliance trends, and lead global initiatives ensuring alignment with ISO standards and U.S. regulations.

Qualifications

• B.S. or B.A. in engineering or a technical field.
• 8+ years in a regulated field (medical devices, IVDs, pharmaceuticals, or biologics).
• Experience managing Quality/Regulatory/Compliance and/or Improvement operations.
• Process excellence certification preferred (SSGB, lean, etc.).
• Strong influencing, communication and project management skills in a global matrix environment.

Responsibilities

• Maintains comprehensive knowledge of applicable regulatory requirements and interpretations, proactively monitors emerging Q&R compliance trends, and effectively communicates relevant external insights across Waters to support ongoing compliance and drive continuous improvement.
• As GPO partners with stakeholders to lead the development of strategies and tools to ensure effective execution and monitoring.
• Supports Leadership Team in designing and implementing global initiatives and change management plans.
• Provides leadership and guidance in timely communication/escalation to senior leadership of issues associated with Q&R Compliance risk via the Waters escalation process.
• Works with business units, regions and sites to ensure Q&R Compliance Scan activities are accomplished; includes content / visualization development, data collection, communication, analysis, reporting and maintenance of the global site list.
• Participates in other key initiatives and projects as necessary to support the Quality Systems team.

Skills

Analytical

Regulatory knowledge

Cross-functional

Communication

Project management

Education

Engineering degree

Tools

PowerBI

SharePoint

Excel

Visio

Job description

BD is a global medical technology leader, seeking a Senior Manager of Quality Systems Compliance to drive regulatory governance and continuous improvement across Waters’ operations. This role focuses on visibility of compliance risks, metrics, and governance across executive forums.

You will partner with cross-functional leadership to implement regulatory programs, monitor compliance trends, and lead global initiatives ensuring alignment with ISO standards and U.S. regulations.