External Manufacturing Quality Manager – 2 Roles

Kenvue

External Manufacturing Quality Manager responsible for compliance and quality assurance at external manufacturing sites for Kenvue products. Leading quality initiatives and managing a team to uphold regulatory standards.

Posted 7/29/2026full-timeSummit • New Jersey • 🇺🇸 United StatesSeniorLead💰 $124,100 - $175,200 per yearWebsite

Core Competencies

Role fit

Core Competencies

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

Demonstrates expertise in quality systems and compliance within regulated industries, with a strong focus on cGMP requirements and regulatory authority practices. Proven ability to lead cross-functional teams, drive process improvements, and develop effective strategies to ensure product quality and compliance.

Highest-signal resume keywords

CGMP RequirementsQuality Compliance ManagementProcess ValidationRegulatory Inspections FacilitationRoot Cause Analysis Techniques

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ValidationCleaning ValidationMicrobiological ControlsQuality Systems OversightRegulatory ComplianceData Collection and Analysis5-WhysFishbone AnalysisFMEADMAIC

Soft Skills

Strong Communication SkillsInterpersonal SkillsCollaborationAdaptabilityCritical Analysis

Industry Keywords

Regulated IndustryFDA EnforcementExternal ManufacturingSupplier ComplianceMatrix Environment

Tech Stack

Tools & technologies

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About the role

Key responsibilities & impact

Responsible for the performance of a select portfolio of EM sites that may include multiple product classes, technologies, and complexities.
Responsible for oversight of quality systems aspects as applicable.
Develop, implement, and oversee execution of strategies, plans, and initiatives to ensure production of Kenvue products that consistently meet Kenvue and Health Authority requirements for Quality and compliance.
Develop aligned, respectful, and productive relationships with Kenvue and EM peer and leadership partners across multiple responsibility levels and within a high matrix structure.
Work with senior leadership to advance the organization and drive improvement.
Set reasonable expectations, gain agreement, develop mutually accepted actions, and coordinate execution strategies.
React decisively to a wide range of non-conformance events, CAPAs, and other quality/compliance indicators.
Drive short and long-term remediation actions that meet requirements and create an improved future state.
Provide expertise, oversight, mentoring, and guidance to others, developing expertise and driving decision-making capabilities to lower levels and across functions.
Drive system and process improvements to deliver enhanced team performance.
Approve the work of others, ensuring quality and compliance to strategies, plans, standards, procedures, and health authority regulations.
Review and approve Annual Drug Product Reviews.
Lead and/or participate as a key contributor to cross-function, cross region, cross sector teams addressing high complexity/high impact issues, initiatives, and strategies.
Maintain the voice of Make Quality, while assuming a global business partner perspective.
Develop a fully effective, motivated, engaged, and compliant team of direct and indirect employees.
Develop and implement experience and skill development strategies that best position the team to meet current and future business needs.
Work in cooperation with each employee to develop personal career strategies.

Requirements

What you’ll need

Bachelor’s degree or equivalent in Engineering, Science, or a related field
A minimum of 8 years of experience working in a regulated industry is required.
Working knowledge of cGMP requirements, current FDA enforcement issues and current regulatory authority enforcement practices is required.
Working knowledge of process validation, cleaning validation, manufacturing and packaging equipment train designs, microbiological controls, and assessing compliance to regulations is required.
Experience in managing quality activities for large volume external manufacturing and supplier sites ensuring compliance with applicable regulations.
Demonstrated ability to collaborate with internal and external partners to enhance relationships and interactions.
Experience in the facilitation of internal and external audits and regulatory inspections.
Demonstrated ability to build respectful and productive relationships with subordinates, peers, and leadership partners across multiple responsibility levels and within a high matrix structure is required.
Demonstrated skills navigating within a matrix environment, managing complexity, collaborating across boundaries, and influencing with and without line authority is also required.
Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
Demonstrated ability to lead and/or work as a key team member, developing strategy/plans and implementing successful outcomes is required.
Demonstrated ability to address complex issues using deductive reasoning, critical analysis skills and systematic approaches is required.
Demonstrated working knowledge of root cause analysis techniques including but not limited to brainstorming, data collection and analysis tools, 5-whys, Fishbone (cause and effect), FMEA, and DMAIC is required.
Results-oriented with strong track record of success in delivering on objectives.

Benefits

Comp & perks

Competitive Benefit Package*
Paid Company Holidays
Paid Vacation
Volunteer Time
Learning & Development Opportunities