Global QMS Leader — Quality Systems & Compliance

Brighter Signals; Cincinnati (OH); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Vacation time

Holiday pay

Parental Leave

Job summary

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems to lead the strategy, governance, and global compliance of our QMS across Auris sites, including Cincinnati and Santa Clara. The role drives quality excellence, inspection readiness, and digital transformation initiatives that support regulatory compliance and product quality throughout the lifecycle.

You will collaborate with Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical teams to ensure

Qualifications

• Bachelor’s degree in a relevant field required.
• 10+ years in Quality Systems leadership in medical devices/pharma/regulatory environments.
• Proven experience with FDA QSR 21 CFR Part 820, ISO 13485, EU MDR, and multi-site inspections.

Responsibilities

• Lead strategy and governance for the Quality Management System across global sites.
• Drive regulatory inspection readiness and remediation programs.
• Oversee governance of quality objectives, KPIs, and continuous improvement initiatives.
• Partner with Quality, Compliance, R&D, Supply Chain, Regulatory, and Clinical teams.

Skills

Quality management

CAPA

Regulatory compliance

Data integrity

Leadership

Risk management

Process improvement

GxP

Auditing

Cross-functional collaboration

Education

Bachelor’s degree

Advanced degree (MS/MBA)

Job description

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems to lead the strategy, governance, and global compliance of our QMS across Auris sites, including Cincinnati and Santa Clara. The role drives quality excellence, inspection readiness, and digital transformation initiatives that support regulatory compliance and product quality throughout the lifecycle.

You will collaborate with Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical teams to ensure