Senior Global Quality & Regulatory Compliance Lead

BD; Cockeysville (MD); Vor Ort; USD 150.000 - 239.000; Vollzeit

Zusammenfassung

BD, a global medical technology leader, seeks a Sr. Manager Quality Systems Compliance in Sparks, MD. This role drives regulatory governance, risk management, and continuous improvement, reporting to executives.

The GPO collaborates with cross-functional leaders to implement new and revised regulations globally, ensuring robust Q&R systems across Waters and BD. Ideal candidates bring deep ISO and US/international regulatory knowledge for medical devices/IVDs, plus strong communication, project

Qualifikationen

• BS/BA in engineering or technical field required.
• 8+ years in a regulated field (medical devices, IVDs, pharma, or biologics).
• Experience managing Quality/Regulatory/Compliance operations.
• Process excellence certification preferred (SSGB, Lean, etc.).
• Strong influencing, communication and project management skills in a global matrix environment.

Aufgaben

• 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. Reviews the data collection methodology to drive efficiency and effectiveness.
• Participates in other key initiatives and projects as necessary to support the Quality Systems team.

Kenntnisse

Analytical skills

Communication skills

Project management

Cross-functional collaboration

Interpersonal skills

Ausbildung

Bachelor's degree in engineering or technical field

Process excellence certification (preferred)

Tools

SharePoint

PowerBI

Excel

Word

PowerPoint

Visio

Jobbeschreibung

BD, a global medical technology leader, seeks a Sr. Manager Quality Systems Compliance in Sparks, MD. This role drives regulatory governance, risk management, and continuous improvement, reporting to executives.

The GPO collaborates with cross-functional leaders to implement new and revised regulations globally, ensuring robust Q&R systems across Waters and BD. Ideal candidates bring deep ISO and US/international regulatory knowledge for medical devices/IVDs, plus strong communication, project