Quality Assurance Manager

Johnson & Johnson

. Lead and oversee quality systems, processes, and controls at external manufacturing sites .

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 quality oversight of external partners and driving continuous improvement initiatives. Proficient in analyzing quality metrics and leading cross-functional teams to enhance processes and ensure compliance with Good Manufacturing Practices.

Highest-signal resume keywords

Quality Assurance ManagementFDA/EMA Regulatory ExperienceGood Manufacturing PracticesQuality Oversight of External PartnersAnalytical Capabilities

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Quality Systems DocumentationChange ControlCAPA PlansQuality Metrics AnalysisAseptic Pharmaceutical ManufacturingGood Tissue PracticesBiologics ProductsTechnical StudiesProduct DispositionValidation Documentation

Soft Skills

Interpersonal SkillsWritten CommunicationOral CommunicationStakeholder InfluenceProblem Resolution

Industry Keywords

FDA RegulationsEMA RegulationsQuality ControlCompliance GuidanceContinuous ImprovementHealth Authority InspectionsTech TransferNew Product IntroductionQuality CultureRisk-Based Decision-Making

About the role

Key responsibilities & impact

Lead and oversee quality systems, processes, and controls at external manufacturing sites
Manage quality oversight in the 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 external manufacturers to improve processes and quality culture
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 people and influence stakeholders with or without direct authority
Support work teams located on-site and remotely
Travel up to 30%

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 own the resolution of complex Quality and Compliance issues with respect to External Manufacturing
Strong analytical capabilities preferred
Experience writing regulatory communications preferred

Benefits

Comp & perks

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 accommodations