Director, Global Specimen Quality Systems

Becton Dickinson; Franklin Lakes (NJ); On-site; USD 212,000 - 339,000; Full time

Job summary

BD, a leading global medical technology company, seeks a senior leader to drive the Specimen Management Quality Systems to meet evolving regulatory demands. You will shape QMS strategy, coordinate internal and external audits, and partner with global teams to ensure compliant, high-quality products.

The role requires a deep regulatory background, extensive QA leadership experience, and the ability to influence across a complex, matrixed organization. Travel to SM entities worldwide is expected.

Qualifications

• BS degree in a technical field is required.
• 10+ years of QA leadership experience in a global matrix organization.
• Expert knowledge of FDA QSR, ISO-13485, EU MDR/IVDR.
• Certifications in CQE/CSQE/CQA/CQM are strongly preferred.
• Experience with QMS software like Trackwise, SAP, PEGA is desirable.

Responsibilities

• Lead Specimen Management Quality Systems to meet regulatory demands.
• Ensure SM QMS is compliant, efficient and scalable.
• Coordinate audits and regulator communications.
• Develop long-term QMS strategy for SM QMS.
• Lead cross-functional QA initiatives.

Skills

QA leadership

Regulatory knowledge

Audits coordination

Cross-functional leadership

Communication

Education

BS degree in a technical field

Tools

Trackwise

SAP

PEGA Systems

Job description

BD, a leading global medical technology company, seeks a senior leader to drive the Specimen Management Quality Systems to meet evolving regulatory demands. You will shape QMS strategy, coordinate internal and external audits, and partner with global teams to ensure compliant, high-quality products.

The role requires a deep regulatory background, extensive QA leadership experience, and the ability to influence across a complex, matrixed organization. Travel to SM entities worldwide is expected.