Senior Quality Systems Leader, Global Compliance

Brighter Signals; Santa Clara (CA); On-site; USD 122,000 - 213,000; Full time

Benefits offered by this job

Vacation time (120 hours/year)

Parental Leave

Comprehensive benefits

Job summary

Johnson & Johnson seeks a Senior Manager, Quality Management Systems to lead QMS strategy, governance, and global compliance across Auris sites. This role partners with Quality, Compliance, R&D, Supply Chain, Regulatory Affairs and Clinical to ensure scalable, compliant systems that support lifecycle quality.

The role emphasizes inspections readiness, data integrity, and digital transformation initiatives to improve efficiency and risk-based decision making, with leadership across a matrix

Qualifications

• Minimum 10 years of progressive Quality Systems, Quality Assurance, or Compliance leadership experience.
• Minimum 5 years leading people, programs, and cross-functional initiatives.
• Demonstrated expertise in FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and international standards.
• Proven success leading regulatory inspections and remediation initiatives.
• Strong collaboration with senior leaders to drive quality strategy and risk-based decisions.

Responsibilities

• Lead strategy and governance for the Quality Management System across sites.
• Drive compliance for global inspections, audits, and regulatory readiness.
• Present executive-quality metrics and drive continuous improvement programs.
• Advance digital quality transformation and data integrity across platforms.
• Mentor a global Quality Systems organization and align across functions.

Skills

Strategic Leadership

Regulatory Compliance

Quality Management Systems

Cross-functional Collaboration

Digital Transformation

Inspection Readiness

Project Management

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field

Advanced degree (Master’s, MBA, or equivalent)

Tools

eQMS

FDA QSR knowledge

ISO 13485

Job description

Johnson & Johnson seeks a Senior Manager, Quality Management Systems to lead QMS strategy, governance, and global compliance across Auris sites. This role partners with Quality, Compliance, R&D, Supply Chain, Regulatory Affairs and Clinical to ensure scalable, compliant systems that support lifecycle quality.

The role emphasizes inspections readiness, data integrity, and digital transformation initiatives to improve efficiency and risk-based decision making, with leadership across a matrix