Senior Manager, Quality Management Systems

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 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 were 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 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

Quality Management System Leadership

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.

Qualifications

Required Education

A minimum of a Bachelors degree is required. Degrees in Engineering Life Sciences Quality Regulatory Affairs or related technical discipline are preferred.

Preferred Education

Advanced degree (Masters MBA or equivalent) in Engineering Life Sciences Quality Regulatory Affairs or related field preferred.

Required 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 Making

Continuous Improvement Mindset

Digital Transformation Leadership

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment as well as get a parents consent for the background check.

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 .Internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills:

Preferred Skills:

Collaboration Compliance Management Consulting Corrective and Preventive Action (CAPA) Data Quality Developing Others Incident Management Inclusive Leadership Leadership Operations Management Performance Measurement Quality Control (QC) Quality Management Systems (QMS) Quality Services Quality Standards Risk Management System Integration Systems Analysis Tactical Planning Team Management

The anticipated base pay range for this position is :

$142000.00 - $244950.00

Additional Description for Pay Transparency:

Base pay range for candidates in Cincinnati OH: $122000-$212750

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off 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 period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Senior Manager