Staff Quality Specialist, Comm. Quality

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

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Kenvue Is Currently Recruiting For a

Staff Quality Specialist, Comm. Quality

What We Do

At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® that you already know and love. Science is our passion; care is our talent.

Who We Are

Our global team is ~ 22,000 brilliant people with a workplace culture where every voice matters, and every contribution is appreciated. We are passionate about insights, innovation and committed to delivering the best products to our customers. With expertise and empathy, being a Kenvuer means having the power to impact millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage – and have brilliant opportunities waiting for you! Join us in shaping our future–and yours.

Role Reports To

Commercial Quality Sr Manager NA

Location

North America, United States, New Jersey, Summit

Work Location

Hybrid

What You Will Do

What the Staff Quality Specialist, Commercial Quality provides regional quality support for commercial, transportation, and customer service operations across North America. This role helps ensure that operations comply with company quality systems, regulatory requirements, and current Good Manufacturing Practices (cGMPs).

The position partners with Deliver, regional operations, Make Quality, Distribution Center Quality, and other cross-functional teams to strengthen quality controls, improve service models, reduce nonconformances, and support reliable delivery of quality products through our supply chain and to consumers on time and in full.

Responsibilities

• Support the development, implementation, and maintenance of processes and controls for commercial and transportation operations in accordance with company policies, procedures, global quality systems, applicable regulations, and cGMPs.
• Lead regional improvement strategies, including the development, implementation, and optimization of quality service models.
• Support Regional Quality Objectives by helping define measures, monitoring progress, and presenting quality performance through metrics, scorecards, and quality reviews with Deliver Operations.
• Ensure compliant regional execution of transportation lane-mapping studies, transportation mode qualifications, and transportation temperature-control and monitoring systems.
• Provide supplier quality support for transportation and temperature-control suppliers in accordance with applicable purchasing-control procedures.
• Lead reviews of transportation-related temperature excursions and assess potential product-quality impact.
• Partner with Internal and External Manufacturing Quality, Distribution Center Quality, Deliver, Customer Service, and other business teams to resolve quality issues and improve processes.
• Lead or participate in product and process risk assessments.
• Ensure Non-Conformances and CAPAs related to commercial and transportation operations are initiated, assigned, investigated, documented, completed, and checked for effective resolution.
• Implement projects that reduce nonconformances, improve cycle times, increase efficiency, and support cost-improvement objectives without compromising quality or compliance.
• Educate business partners on quality-system requirements and their effect on product quality and regulatory compliance.
• Represent Quality in cross-functional projects, governance meetings, process-improvement work, and innovation initiatives.
• Support audit and inspection readiness and participate in audits or regulatory inspections as assigned.
• Balance competing priorities, address time-sensitive quality issues, and support the development of colleagues through coaching and knowledge sharing.

Required 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, over-the-counter 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.

Desired Qualifications

• Advanced degree in a relevant scientific, engineering, quality, or business discipline.
• ASQ or project-management certification.
• Experience conducting or hosting audits and regulatory inspections.
• Experience with continuous-improvement methods.
• Experience with transportation quality, temperature-control systems, lane-mapping studies, transportation mode qualification, or supplier quality management.
• Experience using quality metrics, scorecards, and trend analysis to guide decisions and communicate performance.
• Experience coaching or mentoring colleagues.

Travel: Up to 10%

People leadership: May oversee 0 to 1 contractor or other direct/indirect resource

What’s In It For You

Annual base salary for new hires in this position ranges:

$110,500.00 - $156,000.00

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks
• This list could vary based on location/region
• Note: Total Rewards at Kenvue include salary, bonus (if applicable) and benefits. Your Talent Access Partner will be able to share more about our total rewards offerings and the specific salary range for the relevant location(s) during the recruitment & hiring process.

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment based on merit without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.