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Kenvue

External Manufacturing Quality Lead

Kenvue

External Manufacturing Quality Lead overseeing GMP quality assurance for Kenvue’s OTC, medical device, and cosmetics contract manufacturers. Driving investigations, CAPAs, compliance improvements, and product disposition across North America.

Posted 8/5/2026full-timeGuelph • New Jersey • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit
Core Competencies

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

Demonstrates expertise in Quality Assurance leadership within regulated environments, focusing on compliance, quality improvement, and effective collaboration with cross-functional teams. Proficient in developing and implementing quality management systems and driving compliance initiatives in alignment with cGMP and FDA standards.

Highest-signal resume keywords
Quality Assurance LeadershipCGMP RequirementsCAPA ManagementQuality Improvement ProgramsCross-Functional Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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

Hard Skills
Quality Assurance ProcessesSOP DevelopmentRisk AssessmentData AnalyticsTechnical TransferValidation ActivitiesPerformance Metrics ReviewNonconformance ResolutionRoot-Cause AnalysisCompliance Documentation
Soft Skills
LeadershipAutonomous Problem-SolvingCommunicationNegotiationTeam Collaboration
Tools & Technologies
MS WordMS ExcelMS PowerPoint
Industry Keywords
OTC DrugsMedical DevicesCosmeticsGMP EnvironmentFDA ComplianceQuality SystemsContinuous ImprovementHigh-Performance CultureManufacturing ComplianceQuality Management Systems

About the role

Key responsibilities & impact
  • Provide overall Quality Assurance leadership for contract manufacturers producing OTC drugs, medical devices, cosmetics, and related products for Kenvue
  • Support contract manufacturing sites and drive compliance and quality improvements
  • Resolve nonconformance issues and monitor complaints
  • Review annual reports and report performance metrics
  • Collaborate with business partners and provide batch release support as needed
  • Serve as QA representative on project and improvement teams
  • Guide establishment of quality and compliance requirements
  • Develop SOPs and specifications
  • Support technical transfer and validation activities
  • Oversee applicable quality systems
  • Serve as a subject matter expert for quality assurance processes, procedures, and activities
  • Communicate key initiatives and issues to senior cross-functional leadership
  • Document rationales for product disposition, risk assessment and mitigation, nonconformances, corrective actions, and audit observation responses
  • Conduct and document investigations and CAPAs for high-risk and high-complexity issues
  • Troubleshoot quality and compliance issues and develop root-cause solutions
  • Design and implement quality and compliance improvement programs and initiatives
  • Lead continuous improvement projects
  • Represent Make Q&C on high-impact projects as the Voice of Quality
  • Manage and prioritize complex workloads and deliverables
  • Make product disposition and compliance decisions
  • Review and approve compliance records, specifications, site documentation, procedures, and other documents
  • Lead development and introduction of processes and procedures affecting multiple functions or regions
  • Drive closure of MAPs through engagement and negotiation with External Manufacturing

Requirements

What you’ll need
  • Bachelor’s degree or equivalent
  • Minimum of six (6) years of relevant work experience in a GMP environment
  • Experience leading and owning investigations, CAPAs, and/or CAPA action items or deliverables
  • Demonstrated ability to design and implement quality and compliance improvement programs
  • Detailed working knowledge of cGMP requirements and current FDA enforcement issues
  • Proficiency in MS Word, Excel, and PowerPoint
  • Demonstrated ability to lead cross-functional teams and collaborate with internal and external partners
  • Experience interfacing with senior management to inform, drive change, and provide direct feedback
  • Demonstrated ability to work autonomously on complex or ambiguous issues with little or no daily direction
  • Desired: expertise developing and deploying innovative quality management systems in complex, regulated manufacturing environments
  • Desired: experience using advanced data analytics tools for quality improvements and strategic decision-making
  • Desired: ability to anticipate future quality challenges and design scalable solutions
  • Commitment to leadership imperatives and fostering a high-performance culture aligned with organizational values

Benefits

Comp & perks
  • Competitive Benefit Package
  • Paid Company Holidays
  • Paid Vacation
  • Volunteer Time
  • Learning & Development Opportunities
  • Kenvuer Impact Networks
  • Inclusive benefits for Kenvuers and families