Senior Manager, Quality Management Systems

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); On-site; USD 142,000 - 245,000; Full time

Benefits offered by this job

401(k) plan

Vacations 120 hours/year

Sick time 40 hours/year

Holiday pay 13 days/year

Parental Leave 480 hours/year

Bereavement Leave 240 hours/year

Job summary

Johnson & Johnson is seeking a Senior Manager, Quality Management Systems to lead the MedTech QMS in Santa Clara, CA (or Cincinnati, OH). You will drive strategic quality initiatives, ensure regulatory alignment, and prepare for FDA inspections.

The role requires a strong background in GMP/GDP, ISO 13485, EU MDR, and global quality systems, with a focus on continuous improvement and risk-based decision making.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years in quality systems or compliance leadership in regulated healthcare.
• Experience leading regulatory inspections and audits in medical devices.
• Strong knowledge of GMP, GDP, data integrity and risk management.

Responsibilities

• Develop and align the Quality Management System with business goals and regs.
• Lead enterprise QMS optimization and cross-functional quality initiatives.
• Oversee document control, CAPA, training, and records management teams.
• Establish KPIs and drive continuous improvement and inspection readiness.
• Prepare for FDA inspections and Notified Body audits; ensure global compliance.
• Partner with leadership to identify risks and implement mitigations.

Skills

Quality mgmt systems

Regulatory compliance

FDA QSR

ISO 13485

EU MDR

MDSAP

Leadership

Audit readiness

Education

Bachelor's degree

Advanced degree preferred

Tools

eQMS

AI-enabled quality platforms

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 & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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

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.
• 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.

Qualifications

• Education: A minimum of a Bachelor’s degree is required. Degrees in Engineering, Life Sciences, Quality, Regulatory Affairs, or related technical discipline are preferred.
• Preferred Education: Advanced degree (Master’s, MBA, or equivalent) in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field preferred.
• Experience: 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.

Preferred Experience

• 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.

Leadership Competencies

• Strategic Thinking
• Enterprise Leadership
• Quality and Compliance Excellence
• Change Leadership
• Talent Development
• Stakeholder Influence
• Risk-Based Decision MakingContinuous Improvement Mindset
• Digital Transformation Leadership

Benefits and Compensation

• The anticipated base pay range for this position is : $142,000.00 - $244,950.00
• Base pay range for candidates in Cincinnati, OH: $122,000-$212,750
• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• 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 period10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

Company Culture and Diversity Statements

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs.

If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers .Internal employees contact AskGS to be directed to your accommodation resource.

Additional Perks

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 https://www.jnj.com/.

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