Quality System Support Lead

Kenvue; Las Piedras (PR); On-site; USD 91,000 - 128,000; Full time

Benefits offered by this job

Competitive benefits

Holidays & vacation

Volunteer time

Learning & development

Total rewards

Job summary

Kenvue is seeking a Quality Systems Support Lead for an on-site role in Las Piedras, Puerto Rico. You will coordinate Change Controls, APRs, document control, training, and investigations, ensuring regulatory compliance and efficient quality processes.

You will partner cross-functionally to monitor metrics, drive improvements, support audits, and back up the Quality Systems leadership team while advancing site quality initiatives and performance.

Qualifications

• Bachelor's degree in Science, Engineering, Pharmacy, or a related discipline.
• Five to ten years of experience within the pharmaceutical manufacturing industry.
• Strong knowledge of solid dosage manufacturing processes.
• Experience supporting Quality Systems, including Change Controls, Investigations, Document Control, Training, and/or Annual Product Reviews.
• Knowledge of 21 CFR Parts 210/211 and DEA regulations, as well as experience with FDA inspections and site readiness.
• Knowledge of cGMP, QSR, ISO requirements, applied statistics, and failure mode analysis techniques.
• Experience preparing technical reports, metrics, and presentations.
• Strong written and verbal communication skills in English and Spanish.
• Experience working with electronic Quality Systems platforms and document management systems.
• Ability to work independently, manage multiple priorities, and collaborate effectively across functions.
• Regulatory audit support experience.

Responsibilities

• Support the administration, execution, and continuous improvement of Quality Systems processes, including Change Controls, Annual Product Reviews, Document Control, Training, and Investigations.
• Coordinate cross-functional activities to ensure timely completion of quality-related initiatives and commitments.
• Monitor, analyze, and report Quality Systems metrics, trends, and performance indicators.
• Identify recurring issues, quality risks, and process improvement opportunities and communicate recommendations to leadership.
• Develop, revise, and implement procedures, specifications, and policies to ensure compliance with regulatory and internal requirements.
• Support regulatory inspections and external audits as required.
• Represent Quality Systems in cross-functional meetings, projects, and governance forums as needed.
• Serve as backup to the Quality Systems Manager and support the coordination of departmental priorities and activities.

Skills

Quality Systems knowledge

Bi-lingual English/Spanish

Regulatory compliance

Analytical skills

Education

Bachelor’s degree in Science/Engineering/Pharmacy

Tools

Electronic Quality Systems

Document management systems

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

Quality System Support 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

COMPLIANCE MANAGER

Location

North America, United States, Puerto Rico, Las Piedras

Work Location

Fully Onsite

What You Will Do

This position reports to the Compliance Manager and is an on-site role based in Las Piedras, Puerto Rico. The Quality Systems Support Lead supports the coordination and continuous improvement of key Quality Systems, including Change Controls, Annual Product Reviews (APR), Document Control, Training, and Investigations. This role partners cross-functionally to ensure compliance with cGMP requirements, FDA regulations, internal procedures, and quality standards while driving the timely execution and effectiveness of Quality Systems processes. The position also serves as a backup to the Quality Systems leadership team and supports key site initiatives related to quality and compliance.

Key Responsibilities

• Support the administration, execution, and continuous improvement of Quality Systems processes, including Change Controls, Annual Product Reviews, Document Control, Training, and Investigations.
• Coordinate cross-functional activities to ensure timely completion of quality-related initiatives and commitments.
• Monitor, analyze, and report Quality Systems metrics, trends, and performance indicators.
• Identify recurring issues, quality risks, and process improvement opportunities and communicate recommendations to leadership.
• Develop, revise, and implement procedures, specifications, and policies to ensure compliance with regulatory and internal requirements.
• Support regulatory inspections and external audits as required.
• Represent Quality Systems in cross-functional meetings, projects, and governance forums as needed.
• Serve as backup to the Quality Systems Manager and support the coordination of departmental priorities and activities.

Quality Systems Management

• Support the full lifecycle management of Change Controls, including review, approval, implementation, closure, system administration, metrics monitoring, and user support.
• Coordinate and prepare Annual Product Reviews (APRs), ensuring timely completion, approval, trend analysis, and compliance with applicable procedures.
• Support Document Control activities, including periodic review, approval, maintenance, and effectiveness of controlled documents and SOPs within electronic systems.
• Participate in Training Program activities, including curriculum development, training effectiveness assessments, compliance monitoring, and training requirement evaluations.
• Support investigations related to non-conformances, process failures, and quality events, ensuring root causes are identified and effective corrective and preventive actions are implemented.

Analytics & Continuous Improvement

• Analyze quality system trends, recurring situations, and significant quality events to drive continuous improvement.
• Develop reports, dashboards, and presentations to support Quality Council reviews and leadership decision-making.
• Participate in Communities of Practice and cross-site initiatives to drive standardization, best practices, and compliance excellence.
• Support implementation of action plans resulting from audits, inspections, investigations, and quality reviews.

Required Qualifications

What We Are Looking For

• A minimum of a Bachelor’s degree in Science, Engineering, Pharmacy, or a related discipline.
• Five to ten years of experience within the pharmaceutical manufacturing industry.
• Strong knowledge of solid dosage manufacturing processes.
• Experience supporting Quality Systems, including Change Controls, Investigations, Document Control, Training, and/or Annual Product Reviews.
• Knowledge of 21 CFR Parts 210/211 and DEA regulations, as well as experience with FDA inspections and site readiness.
• Knowledge of cGMP, QSR, ISO requirements, applied statistics, and failure mode analysis techniques.
• Experience preparing technical reports, metrics, and presentations.
• Strong written and verbal communication skills in English and Spanish.
• Experience working with electronic Quality Systems platforms and document management systems.
• Ability to work independently, manage multiple priorities, and collaborate effectively across functions.
• Regulatory audit support experience.

Preferred Qualifications

• Green Belt certification.
• Project Management certification.
• Knowledge of KPS and Process Excellence methodologies.
• Experience serving as a system administrator or power user for electronic Quality Systems platforms.

What’s In It For You

Annual base salary for new hires in this position ranges: $90.950,00 - $128.400,00 This takes into account a number of factors including work location, the candidate’s skills, experience, education level & other job-related factors.

• 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.