Senior Manager, Quality Management Systems

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, and solutions are personal.

Through our expertise in Innovative Medicine and Med Tech, 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.

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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.

Quality

Quality Systems

People Leader

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

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

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

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.

• 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.

• 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.

• 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.

• 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…