Quality Systems Lead

Quality Systems Lead

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. For more information, click here.

Role reports to:

Senior Manager, Quality Systems

Location:

North America, United States, New Jersey, Summit

Work Location:

Hybrid

What you will do

The Quality Systems Lead’s primary focus will be regulatory standards management, supporting the monitoring, assessment and implementation of new or revised GxP regulations and standards across North America. The Quality Systems Lead translates regulatory requirements into practical business actions, coordinates cross-functional impact assessments, monitors implementation workstreams, and identifies and escalates key risks and concerns to support effective oversight and decision making. The role works with regional and global stakeholders to support timely compliance, communicate regulatory changes and escalate risks.

The role will also support other areas of quality systems and compliance based on business needs and priorities, which may include quality system process improvements such as change control, investigations and corrective and preventive actions (CAPA), governance reporting, and audit and inspection readiness. These responsibilities will involve cross-functional collaboration to strengthen process consistency, maintain effective compliance oversight and support continuous improvement across North America.

Key Responsibilities

• Monitor new and revised approved regulations and standards within the assigned geographic and functional scope. Communicate relevant changes promptly to allow assessment and implementation before regulatory effective dates. Monitor draft regulations when assigned to support readiness for potential changes.
• Determine regulatory applicability by product category, business function, process and market. Review existing/new RTC records and support coordination across regions.

Core competency around:

• Apply working knowledge of product formulations, including the functions of active and inactive ingredients, raw material attributes and finished-product specifications, to support regulatory applicability and product impact assessments.
• Demonstrate an understanding of formulation-related quality considerations, including ingredient compatibility, stability, physicochemical properties, microbiological quality and packaging compatibility, and collaborate with technical subject matter experts to assess potential compliance implications.
• Partner with Research and Development, Regulatory Affairs, Manufacturing and Quality teams to assess changes to formulations, raw materials or specifications through applicable change control processes, supporting documented evaluation of product quality, testing, validation and regulatory impacts.

• Coordinate documented impact and gap assessments with subject matter experts. Evaluate implications for products, quality systems, operating procedures, training, resources and regulatory filings, as applicable.

• Track implementation through completion via applicable quality system processes, including change control, document revisions, training, and investigations or corrective and preventive actions (CAPA).
• Support compliance before regulatory effective dates. Promptly escalate immediately effective requirements, when implementation cannot meet regulatory effective dates. Assess risk and mitigation activities when missed implementation timelines result in noncompliance.

• Support audit and inspection readiness by maintaining accessible, traceable regulatory assessment and implementation documentation.
• Strong working knowledge of Quality System elements, including Metrics, Audits, and General Quality System processes.
• Strong influencing skills with the ability to engage and guide leaders, peers, and teams without direct authority.
• Excellent written and verbal communication skills.

• Analyze quality metrics and process trends to support management reviews, risk-based prioritization, timely escalation and monitoring of quality system effectiveness.

What we are looking for

Required Qualifications:

• BS/MS is Sciences/Engineering
• 5+ years of experience in Regulatory Affairs, Quality Systems, Compliance or a related field.
• Experience in product development or packaging, or knowledge of product and packaging requirements.
• Working knowledge of applicable regional and global regulatory requirements, GMP/cGMP and quality management systems.
• Experience managing regulatory implementation programs, global standards, cross-functional projects or change initiatives.
• Ability to interpret new or revised requirements, conduct gap and impact assessments, and translate findings into practical business actions.
• Understanding of risk management, CAPA, change control and document management processes.
• Familiarity with RTC/Power Apps, EtQ and Power BI reporting.
• Strong analytical skills, including the ability to evaluate compliance risks, identify trends and develop meaningful performance reporting.
• Clear written and verbal communication, including preparation of executive summaries, governance updates and guidance for operational teams.
• Ability to influence without direct authority, build cross-functional alignment and coordinate implementation across functions or regions.

Preferred Qualifications:

• Experience in consumer health, pharmaceuticals, medical devices or another regulated industry.
• Experience with regulatory tracking or document management platforms, such as Veeva.
• Relevant certifications, such as RAC, ASQ CQA or CMQ/OE, Lean Six Sigma, or ISO 9001/GMP-related credentials, are advantageous but not mandatory.

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What’s in it for you

$110,500.00 - $156,000.00

This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

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.