Description

Kenvue is currently recruiting for:
External Quality Lead-NPI
Who we are
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 Brand Adhesive Bandages that you already know and love. Science is our passion; care is our talent. Our global team is made up of 22,000 diverse and brilliant people, 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 the life of 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: External Quality Manager-NPI
Location: Skillman, NJ (Kenvue's corporate headquarters is currently located in Skillman NJ, but is scheduled to move to Summit, NJ in or around early 2025.)
Travel : 10%
Pay: $88,000- 142,600

What you will do
The External Quality Lead-NPI under minimal supervision is responsible for supporting NPI activities at Contract Manufacturing sites, driving compliance & quality improvement initiatives, reports, tracks and follows up on deficiencies including assessments, investigations and over all site performance. Proactively participate on new product development / Technical Transfer teams and ensure that all projects meet specified QA launch requirements and timelines. Perform First Article Inspection, batch release, review, approve specifications, protocols and reports. Routinely interact with Kenvue business partners and external manufacturing sites supporting commercialization and documentation readiness for product launch. This job position may represent QA on project and improvement teams by guiding setting quality/compliance requirements and development of SOPs.
Subject Matter Expert (SME) for quality assurance processes, procedures, and activities. Remain current on assigned quality system training and seek out training and knowledge in adjacent areas. A mentor to junior staff.

Key Responsibilities
Manage NPI projets; First Article of Inspection, batch Release, label review
Reports, tracks, and follows up on deficiencies noted at external manufacturing sites, including assessments, audits, investigations, and overall site performance.
Proactive participation on new product development teams, including coordination with Technical Transfer team, to ensure that all projects meet specified QA launch requirements and timelines.
Guidance and review in the development of APR and change control documentation for new product launches and commercialized products, respectively.
Review of specifications and validation documentation related to base business projects and new product introductions.
Guidance in the implementation of compliance and quality improvement initiatives at external manufacturing sites, during product development, scale-up, validation, and launch.
Routine interaction with internal business partners and external manufacturing sites, in support of commercialization and documentation readiness.
Compliance with processes and controls, as well as with cGMP and FDA guidelines, to ensure that product quality and performance conform to established standards.
Troubleshoots quality problems, provides thorough and practical assistance in the resolution of process / product non-conformance events, and assists in the development of corrective actions to prevent reoccurrence, leveraging Quality Systems.
Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality system gaps and lead continuous improvement projects.
Independently lead and prioritize highly complex and diverse workload ensuring results are on-time, accurate, and meet their intended objective.
Leads the development and introduction of new processes and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency

What we are looking for
Required Qualifications
A minimum of a Bachelor's Degree or higher (Science or Engineering preferred).
A minimum 6 years of expereince in the Personal Care, Cosmetics, OTCs products industry and demonstrated work experience in NPI.
Experience leading and owning investigations, CAPAs and/or CAPA action items or deliverables
Collaborative and successful at establishing relationships with internal and external partners
Thrives in fast-paced environments, able to independently lead and prioritize highly complex and diverse workload ensuring results are on-time, accurate, and meet their intended objective
Desired Qualifications
Experience supporting Internal and/or External (Contract) Manufacturing sites
Understanding of Regulatory requirements and experience in a GMP facility and knowledge of FDA regulations.

What's in it for you
Annual base salary for new hires in this position ranges from $88,000 to $142,600 This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
Competitive Total Rewards Package
Paid Company Holidays, Paid Vacation, Volunteer Time & More!
Learning & Development Opportunities
Employee Resource Groups
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...

Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity