Senior Manager, Quality Management Systems

Johnson & Johnson • Cincinnati, CA

2d • Hybrid

About The Position

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.

Requirements

• A minimum of a Bachelor’s degree is required. Degrees in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline are preferred.
• Minimum 10 years of progressive Quality Systems, Quality Assurance, or Compliance leadership experience within the medical device, diagnostics, pharmaceutical, or regulated healthcare industry.
• Minimum 5 years leading people, programs, and cross-functional initiatives in a matrixed organization.
• Demonstrated expertise in Quality Management Systems and regulatory compliance, including FDA Quality System Regulation (21 CFR Part 820), ISO 13485, EU MDR, and international quality standards.
• Proven success leading regulatory inspections, audit readiness programs, and remediation initiatives.
• Strong understanding of: Good Manufacturing Practices (GMP) Good Documentation Practices (GDP) Data Integrity requirements Risk Management principles Design Controls and Product Lifecycle Management
• Experience driving large-scale process improvement, business transformation, and organizational change initiatives.
• Demonstrated ability to influence senior leadership and drive alignment across multiple organizations.
• Strong business acumen with the ability to translate quality requirements into practical, scalable business solutions.
• Excellent communication, presentation, facilitation, and executive stakeholder management skills.
• Strong analytical, problem-solving, and decision-making capabilities.
• Ability to manage competing priorities in a fast-paced, evolving business environment.

Nice To Haves

• Advanced degree (Master’s, MBA, or equivalent) in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field preferred.
• Experience supporting robotic surgery, medical device, or highly regulated product development organizations.
• Experience implementing or enhancing electronic Quality Management Systems (eQMS), digital quality platforms, and AI-enabled compliance solutions.
• Knowledge of FDA, EU MDR, MDSAP, ISO 14971, IEC 62304, and design control requirements.
• Experience leading global or multi-site Quality Systems organizations.
• Background in engineering, operations, manufacturing quality, design assurance, or quality systems transformation.
• ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certifications preferred.

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.
• 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 technologies that enable proactive quality management and risk-based decision making.
• 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.
• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior