Quality Assurance Manager

Johnson & Johnson

. Provide leadership and oversight for specified external manufacturers of Advanced Therapy products .

Posted 9/23/2026full-timeUnited StatesSeniorLead💰 $102,000 - $177,100 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive knowledge of Quality Assurance, Quality Control, and Compliance within FDA/EMA regulated environments, with a focus on managing external manufacturing partnerships and ensuring adherence to Good Manufacturing Practices.

Highest-signal resume keywords

Quality Assurance ManagementRegulatory Compliance ExpertiseGood Manufacturing PracticesExternal Partner OversightAnalytical Capabilities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality ControlGood Tissue PracticesAseptic Pharmaceutical ManufacturingCAPA PlansQuality Systems DocumentationRisk-Based Decision-MakingTechnical StudiesChange ControlsProduct DispositionManufacturing Instructions

Soft Skills

Interpersonal SkillsWritten CommunicationOral CommunicationLeadershipStakeholder Influence

Industry Keywords

FDA Regulated EnvironmentEMA Regulated EnvironmentPharmaceutical ProductionContinuous Process ImprovementInspection ReadinessQuality Metrics AnalysisHealth Authority InspectionsCross-Functional CollaborationTech TransferNew Product Introduction

About the role

Key responsibilities & impact

Provide leadership and oversight for specified external manufacturers of Advanced Therapy products
Ensure pharmaceutical products meet safety, regulatory compliance, and product quality standards
Lead people and influence stakeholders while maintaining inspection readiness and regulatory compliance
Lead and oversee quality systems, processes, and controls at external manufacturing sites
Manage selection, qualification, and ongoing monitoring of external partners
Lead identification and resolution of quality issues and complaints, including investigations and CAPA plans
Review and approve quality systems documentation, product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies
Analyze quality metrics and trends to identify risks and improvement opportunities
Build relationships with internal and external partners and influence continuous process improvement
Collaborate with external manufacturers on health authority inspections and follow-up responses and commitments
Serve as the Quality Assurance representative on cross-functional project teams
Provide compliance guidance and risk-based decision-making
Drive continuous improvement initiatives aligned with business objectives and quality strategy
Provide oversight for tech transfer and new product introduction activities
Lead with or without direct authority
Travel up to 30% as required

Requirements

What you’ll need

8+ years working in an FDA/EMA regulated environment
Bachelor’s degree in a scientific, technical, or related discipline required
Extensive knowledge of Quality Assurance, Quality Control and Compliance
Detailed knowledge of current Good Manufacturing Practices related to pharmaceutical production
Experience managing quality oversight of external partners for commercial manufacturing operations
Experience in Good Tissue Practices and Biologics products
Experience in aseptic pharmaceutical manufacturing
Strong interpersonal and written/oral communication skills
Ability to take ownership of and resolve complex Quality and Compliance issues related to External Manufacturing
Strong analytical capabilities preferred
Experience writing regulatory communications 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
Inclusive interview process and disability accommodation support