Kenvue · 3 hours ago
Senior Manager, Regional Product Quality - Skin Health
North America, United States, New Jersey, Summit
Full-time
Hybrid
Senior Level, Lead/Staff
$154K/yr - $217K/yr
8+ years expKenvue is a company that specializes in everyday care products, and they are seeking a Senior Manager, Regional Product Quality for their Skin Health division. This role is responsible for overseeing product quality and compliance throughout the product lifecycle, ensuring adherence to quality systems and regulatory requirements while collaborating with various cross-functional teams.
LifestylePersonal HealthWellness
Responsibilities
Develops, establishes and maintains processes and controls ensuring that the performance and quality of new and reformulated/re-designed products conform to established standards including policies, procedures, U.S. and Global Quality Systems Regulations and current Good Manufacturing Practices (cGMPs)
Partners with Product Development, Technical Operations and Manufacturing functions to define the product and process Critical-to-Quality (CTQ) / Critical Process Parameters (CPPs)
Reviews and approves technical documents related to new product introductions and product changes requiring a Fitness for Commercialization (FFC) document or Global Change Control (GCC) to ensure that all work has been conducted according to the defined success criteria, established procedures and regulatory requirements
Partners with the Raw Material Center to ensure that all new raw materials are qualified and suppliers have been approved in accordance with compliance requirements
Responsible for the final coordination and flawless execution of new product activities between R&D, MAKE Quality, Operations and Supply Chain, including, high quality documentation for Fitness for Commercialization (FFC) document
Partners with Make Quality (Internal and External Manufacturing QA and Supplier Quality) on the transfer of new products and processes to the manufacturing environment establishing clear quality plans and robust process capabilities
Provides ongoing mentoring and coaching of team members. Ensure staff are trained on procedures and systems associated with their assigned tasks. Performs administrative and talent management related tasks
Guides and trains project teams to build in strategic compliance and ensure quality requirements are met during product development, scale up and validation
Educates and empowers business partners to understand quality system requirements and how they impact product quality and regulatory compliance
Leads and/or participates in product and process risk assessments
Serves as a Quality representative on New Product Innovation (NPI) Teams to ensure timely execution of development initiatives
Provides Quality guidance during Technical Review Forums (TRF) by ensuring that data from all functions is reviewed by a cross-functional team and that potential concerns are addressed prior to production or commercialization
Represents Regional Product Quality in innovation forums to ensure that quality and compliance is addressed during the deployment of new products per applicable timelines
May assist in the review of Complaint Vigilance Review Board (CVRB) data in preparation for the CVRB meetings. Highlights any implications to the business identified during the review process
Leads, develops and implements new policies, standards and guidance for new technologies, new businesses and emerging regulations
Reviews product specifications to ensure that design criteria can be met post launch and over the entire shelf life or design life of the product
Ensures that Corrective Actions/Preventive Actions (CAPAs) are initiated, assigned, thoroughly investigated, documented and effectively resolved when deficiencies are found during development, testing and manufacturing
Measure and evaluate performance of the new product commercialization process
Partners with R&D Life Cycle Management, EM/MAKE Q&C, Regulatory Affairs, and Medical Safety to ensure that significant quality issues are appropriately escalated and addressed via Quality Review Board meetings as needed
Support and/or provide guidance and oversight for acquisitions; including business integration and improvement of quality system compliance if required
Serve as back-up to the Regional Product Quality Leader at various governance and franchise forums
Participate in ad hoc special project, process improvement, and innovation teams as needed
Qualification
Required
A minimum of a Bachelor's Degree
A minimum of 8 years of relative business experience in an FDA (or Health Canada) regulated industry
Minimum of 5 years of Quality experience in an FDA (or Health Canada) regulated environment
Experience in Quality Assurance, Quality Systems, and/or New Product Development
Experience with applicable regulatory requirements (cGMPs) governing various product classification types (Cosmetic, OTC/OTC Monograph and Medical Devices)
Experience leading complex and/or strategic projects
Ability to travel up to 10%
Preferred
Other advanced degree
ASQ and/or Project Management certifications
Experience in technical transfer, process development, analytical chemistry, microbiology, product safety, and process validation
Experience conducting or hosting audits and regulatory inspections
Continuous improvement experience and/or approach
Benefits
Competitive Benefit Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Kenvuer Impact Networks
Company
Kenvue
Kenvue is a consumer health company that delivers personal health solutions.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$3.65BKey Investors
Third PointStarboard Value
2025-11-03Acquired
2025-04-25Post Ipo Equity
2024-10-21Post Ipo Equity
Leadership Team
Kirk Perry
Chief Executive Officer and Director at Kenvue
Andrew Stanleick
President, Skin Health & Beauty, North America and EMEA at Kenvue
Recent News
2026-02-03
Hindu Business Line
2026-01-22
Company data provided by crunchbase