Quality System Support Lead

Kenvue•Las Piedras, PR

3d•$90,950 - $128,400•Onsite

About The Position

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. 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.

Requirements

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.

Nice To Haves

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.

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.
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.
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.