Senior Manager, Quality Management Systems

Johnson & Johnson MedTech; Cincinnati (OH); On-site; USD 150,000 - 210,000; Full time

Job summary

Johnson & Johnson MedTech is seeking a Senior Manager, Quality Management Systems to lead the strategy, governance, and global compliance of the Quality Management System across Auris sites. This role partners with Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical to ensure scalable, compliant processes that support product quality through the lifecycle.

The Senior Manager will drive digital transformation initiatives, champion data-driven quality improvement, and

Qualifications

• Lead strategy and governance for the Quality Management System.
• Ensure regulatory compliance with FDA QSR, ISO 13485, EU MDR.
• Collaborate with Quality, Compliance, R&D, Supply Chain and Regulatory Affairs.

Responsibilities

• Develop and execute the strategic roadmap for QMS across sites.
• Drive enterprise-QMS optimization for efficiency and scalability.
• Lead teams supporting Document Control, Training, CAPA, Records Management.
• Oversee inspection readiness and audit remediation programs.

Skills

Quality Systems

Regulatory Compliance

Leadership

Cross-functional collaboration

Digital Transformation

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & J onn, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

Quality Systems

Job Category

People Leader

All Job Posting Locations

Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America

Job Description

We are searching for the best talent for Senior Manager, Quality Management Systems to join our MedTech Quality organization located in Santa Clara, CA or Cincinnati, OH.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Senior Manager, Quality Management Systems (QMS) is responsible for leading the strategy, governance, continuous improvement, and global compliance of the Quality Management System across Auris sites. This role serves as a key leader in driving quality excellence, inspection readiness, operational effectiveness, and digital transformation initiatives that support business growth, regulatory compliance, and product quality throughout the product lifecycle.

The position partners with cross-functional leaders across Quality, Compliance, R&D, Supply Chain, Service, Regulatory Affairs and Clinical to ensure the QMS remains scalable, efficient, and compliant with global regulatory requirements, including FDA QSR, ISO 13485, EU MDR, and other global regulations/standards.

Key Responsibilities

• Develop and execute the strategic roadmap for the Quality Management System, ensuring alignment with business objectives, regulatory requirements, and industry best practices.
• Drive enterprise-wide QMS optimization initiatives to simplify, standardize, and improve quality processes, enhancing compliance, efficiency, and scalability.
• Lead teams supporting: Document Control, Training Management, CAPA, Records Management and additional Quality Subsystems as assigned
• Establish performance metrics and monitoring mechanisms to assess QMS effectiveness and drive a culture of continuous improvement.
  

Regulatory Compliance and Inspection Readiness

• Lead global inspection readiness programs and serve as a strategic quality leader in preparation for FDA inspections, Notified Body audits, and other global health authority assessments.
• Ensure sustained compliance with FDA Quality System Regulations, ISO 13485, EU MDR, MDSAP, and applicable international regulations and standards.
• Partner with site and functional leadership to proactively identify compliance risks and implement effective mitigation strategies.
• Oversee inspection preparation activities, audit response programs, and remediation efforts to ensure timely and sustainable closure of observations.
  

Quality Strategy and Governance

• Lead Quality Systems Management Reviews and provide executive-level reporting on quality system performance, compliance risks, and improvement opportunities.
• Drive governance processes that ensure effective monitoring of quality objectives, KPIs, quality trends, and organizational health.
• Collaborate with platform and enterprise partners to drive implementation and harmonization of global standards, procedures, and quality initiatives.
• Evaluate and lead adoption of Johnson & Johnson enterprise quality processes that improve efficiency, consistency, and compliance across Auris.
  

Digital Quality Transformation

• Champion digital transformation initiatives that modernize quality systems through automation, advanced analytics, AI-enabled solutions, and integrated digital platforms.
• Lead cross-functional transformation programs that improve process efficiency, data integrity, inspection readiness, and overall user experience.
• Drive the implementation of innovative technologies that enable proactive quality management and risk-based decision making.
  

Leadership and Talent Development

• Lead, develop, and mentor a high-performing Quality Systems organization, fostering accountability, engagement, and continuous professional growth.
• Promote a culture of quality, compliance, operational excellence, and risk-based thinking throughout the organization.
• Build strong partnerships across functions and levels of the organization to influence outcomes and accelerate strategic objectives.
• Effectively manage multiple priorities in a dynamic environment while driving alignment and consensus among stakeholders.
  

Organizational Impact

• Serve as a trusted advisor to senior leadership on Quality Systems strategy, compliance trends, regulatory expectations, and business risks.
• Support departmental and organizational objectives while upholding the Johnson & Johnson Credo and all applicable safety, environmental, and ethical standards.
• Drive initiatives that strengthen quality culture, operational resilience, and long-term business success.