Description

Upcoming Quality Lead opportunities here at Kenvue

Location : Summit, New Jersey, US

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.

What will you do
We're launching an exciting Quality Lead opportunity soon and would love to connect if you're interested in learning more. We look forward to reviewing your application should you apply.

As a Quality Lead you will be responsible for responsible for the on-going support to contract manufacturing locations and is responsible for reporting and reviewing Contract Manufacturer performance metrics, support and maintenance of Quality Systems documentation requirements, and conducting reviews as needed. You will Represent EMQA on projects and improvement teams to guide quality/compliance requirements, develop and/or update SOPs as needed, and to provide support to Quality Account Manager for products produced at EM sites.

Key Responsibilities

• Support the production and batch disposition of OTC Drugs which are produced at External Manufacturing (EM) sites.
• Support interactions related to quality assurance and quality controls for solids and liquids products produced at External Manufacturing (EM) sites.
• Support all quality-related activities with an EM site that impact consumer safety or supply chain disruption. This includes, but is not limited to: supply chain disruptions, product release and product distribution.
• Support Quality performance at EM sites. Including, but not limited to support: Change Controls, Manufacturing/Packaging Directions, Stability Sample Management, Batch record/Product Review, Investigation review/approval and CAPA implementation, Audit observation tracking, maintenance of approved supplier list, and providing metrics.
• Support implementation efforts for new product introductions, equipment implementations, process changes, technology transfers, and quality agreements for EM sites.

What we are looking for

Qualifications

• A minimum of a bachelor's degree is required. Degree in Engineering, Life Science, Physical Science, or related discipline is preferred
• A Minimum of 6 years of experience in the pharmaceutical area in a FDA-regulated industry is required.
• Experience in the OTC/pharmaceutical industry is required.
• Knowledge of cGMPs is required.
• Experience working on cross-functional project teams is required.
• Understanding of site quality activities (batch record review, product release, investigation review and approval) is required.

Preferred Qualifications

• Knowledge of Quality Assurance principles and practices in the pharmaceutical, medical device, biological, and/or OTC Drug product industry is preferred.
• Knowledge of product transfers, operations, and validation is preferred.
• Understanding of validation activities (protocol review and approval, product development) is preferred.
• Experience with managing external manufacturing and/or contract packaging is preferred.

What's in it for you

• Competitive Benefit Package*
• Paid Company Holidays, Paid Vacation, Volunteer Time & More!
• Learning & Development Opportunities
• Kenvuer Impact Networks

*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.