Staff Quality Specialist, Commercial Quality — Hybrid NA

Kenvue; Lititz (Lancaster County); Hybrid; USD 111,000 - 156,000; Full time

Benefits offered by this job

Competitive Benefit Package

Paid Company Holidays, Paid Vacation,

Volunteer Time & More

Learning & Development Opportunities

Kenvuer Impact Networks

Note: Total Rewards at Kenvue include

Job summary

Kenvue is seeking a Staff Quality Specialist, Commercial Quality to provide regional quality support across North America. This role ensures operations comply with quality systems, regulatory requirements, and cGMPs in commercial, transportation, and customer service activities.

You will partner with Deliver, regional operations, Make Quality, Distribution Center Quality, and other cross-functional teams to strengthen quality controls, reduce nonconformances, and support reliable delivery of

Qualifications

• Bachelor's degree.
• 6-8 years of relevant business experience in an FDA- or Health Canada-regulated industry.
• Experience in Quality Assurance, Quality Systems, Supply Chain, or Transportation Operations.
• Working knowledge of cGMP requirements applicable to one or more regulated product categories, including cosmetics, OTC products, OTC monograph products, or medical devices.
• Experience leading complex or strategic projects.
• Experience with investigations, root-cause analysis, CAPA, risk assessment, and quality documentation.
• Strong written, verbal, presentation, and interpersonal communication skills.
• Ability to work across organizational boundaries and influence outcomes in a matrix environment, with or without direct authority.
• Ability to analyze complex issues, set priorities, and drive work to completion.

Responsibilities

• Provide regional quality support for commercial, transportation, and customer service operations across North America in accordance with company quality systems and cGMPs.
• Lead regional improvement strategies, including quality service model development and optimization.
• Support Regional Quality Objectives by defining measures, monitoring progress, and presenting quality performance.
• Ensure compliant regional execution of transportation studies and temperature-control and monitoring systems.
• Provide supplier quality support for transportation and temperature-control suppliers per procedures.
• Lead reviews of transportation-related temperature excursions and assess product-quality impact.
• Partner with Internal and External Manufacturing Quality, Distribution Center Quality, Deliver, Customer Service, and other teams to resolve quality issues.
• Lead or participate in product and process risk assessments.
• Ensure Non-Conformances and CAPAs are initiated, investigated, and resolved; implement corrective actions.
• Implement projects to reduce nonconformances, improve cycle times, and support cost-improvement objectives while maintaining quality.
• Educate partners on quality-system requirements and regulatory compliance.
• Represent Quality in cross-functional projects and governance meetings.
• Support audit and inspection readiness and participate in audits/regulatory inspections as assigned.
• Coach and develop colleagues; balance competing priorities and urgent quality issues.

Skills

Quality Assurance

Quality Systems

Supply Chain

Transportation Operations

Investigations

CAPA

Root Cause Analysis

Risk Assessment

Communication Skills

Education

Bachelor's degree

Advanced degree preferred

Job description

Kenvue is seeking a Staff Quality Specialist, Commercial Quality to provide regional quality support across North America. This role ensures operations comply with quality systems, regulatory requirements, and cGMPs in commercial, transportation, and customer service activities.

You will partner with Deliver, regional operations, Make Quality, Distribution Center Quality, and other cross-functional teams to strengthen quality controls, reduce nonconformances, and support reliable delivery of