Global Quality Systems Director

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

Job summary

BD is seeking a senior QA leader to drive Specimen Management Quality Systems, ensuring regulatory compliance across locations. You will guide QMS design, CAPA, change control, document control, and post-market surveillance, while coordinating audits with regulators and internal teams.

The role requires extensive FDA QSR and ISO-13485 knowledge, leadership across a matrix organization, and willingness to travel internationally. Join a team that values impact, growth, and healthcare innovation.

Qualifications

• BS degree in a technical field; knowledge of QMS software tools desirable.
• Experience with FDA QSR, ISO-13485, EU MDR/IVDR regulatory frameworks.
• Led QA or QMS in a matrix global organization; travel required.

Responsibilities

• Lead SM Quality Systems strategy and ensure compliance across locations.
• Coordinate audits, CAPA, Change Control and Document Control activities.
• Develop and implement scalable QMS processes aligned with regulations.
• Engage regulators and internal stakeholders to drive continuous improvement.
• Foster leadership and build quality culture across the organization.

Skills

BS degree

QMS software tools

Regulatory knowledge

Leadership

Audit liaison

Education

BS in a technical field

Tools

Trackwise

SAP

PEGA Systems

Job description

BD is seeking a senior QA leader to drive Specimen Management Quality Systems, ensuring regulatory compliance across locations. You will guide QMS design, CAPA, change control, document control, and post-market surveillance, while coordinating audits with regulators and internal teams.

The role requires extensive FDA QSR and ISO-13485 knowledge, leadership across a matrix organization, and willingness to travel internationally. Join a team that values impact, growth, and healthcare innovation.