Senior Manager, Quality Management Systems

Johnson & Johnson

. Develop and execute the strategic Quality Management System roadmap .

Posted 10/12/2026full-timeUnited StatesSenior💰 $142,000 - $244,950 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems and regulatory compliance, including FDA QSR and ISO 13485, while leading cross-functional initiatives to drive quality improvements and organizational change. Proven ability to influence senior leadership and implement scalable business solutions in a regulated healthcare environment.

Highest-signal resume keywords

Quality Management Systems ExpertiseRegulatory Compliance LeadershipCross-Functional Program ManagementProcess Improvement InitiativesStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsRegulatory ComplianceProcess ImprovementRisk ManagementData IntegrityDesign ControlsAudit ReadinessPerformance MetricsDigital Quality PlatformsAI-Enabled Solutions

Soft Skills

LeadershipAnalytical Problem-SolvingDecision-MakingStakeholder ManagementFacilitation

Tools & Technologies

EQMSDigital PlatformsAutomation ToolsAdvanced Analytics

Certifications & Qualifications

ASQ CQEASQ CQAASQ CMQ/OE

Industry Keywords

FDA QSRISO 13485EU MDRMDSAPGMPGDPMedical DeviceDiagnosticsPharmaceuticalRegulated Healthcare

About the role

Key responsibilities & impact

Develop and execute the strategic Quality Management System roadmap
Drive enterprise-wide QMS optimization to simplify, standardize, and improve quality processes
Lead teams supporting Document Control, Training Management, CAPA, Records Management, and other Quality Subsystems
Establish performance metrics and monitoring mechanisms for QMS effectiveness
Lead global inspection readiness programs for FDA inspections, Notified Body audits, and other health authority assessments
Ensure compliance with FDA QSR, ISO 13485, EU MDR, MDSAP, and applicable international standards
Identify compliance risks and implement mitigation strategies with site and functional leadership
Oversee inspection preparation, audit response, and remediation efforts
Lead Quality Systems Management Reviews and provide executive-level reporting
Drive governance processes for quality objectives, KPIs, quality trends, and organizational health
Collaborate with enterprise partners to implement and harmonize global standards and quality initiatives
Champion digital transformation through automation, advanced analytics, AI-enabled solutions, and integrated digital platforms
Lead cross-functional transformation programs improving efficiency, data integrity, inspection readiness, and user experience
Lead, develop, and mentor a high-performing Quality Systems organization
Advise senior leadership on QMS strategy, compliance trends, regulatory expectations, and business risks
Drive initiatives strengthening quality culture, operational resilience, and long-term business success

Requirements

What you’ll need

A minimum of a Bachelor’s degree is required
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
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
Experience leading regulatory inspections, audit readiness programs, and remediation initiatives
Strong understanding of GMP, 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
Ability to influence senior leadership and drive alignment across multiple organizations
Strong business acumen and 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
Experience supporting robotic surgery, medical device, or highly regulated product development organizations preferred
Experience implementing or enhancing eQMS, digital quality platforms, and AI-enabled compliance solutions preferred
Knowledge of FDA, EU MDR, MDSAP, ISO 14971, IEC 62304, and design control requirements preferred
Experience leading global or multi-site Quality Systems organizations preferred
ASQ certifications (CQE, CQA, CMQ/OE) or equivalent professional certifications preferred

Benefits

Comp & perks

Consolidated retirement plan (pension)
Savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 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