Material Quality Lead

4 weeks ago

Skillman, United States Kenvue NA Full time
Kenvue is currently recruiting for:

Material Quality Lead

This position reports to the Manager, Material Quality and is based at Summit, NJ.

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. For more information, click here.

Role reports to: Manager, Material Quality
Location: Summit, NJ
Travel %: 20
Pay: 92K-149,500

What you will do

The Materials Quality Lead, is responsible for the successful development and implementation of the Supplier Quality Management (SQM) strategy and associated policies, procedures, programs, and initiatives that deliver quality, compliance, material reliability, and/or operating benefit to the supply chain. The Materials Quality Lead actively partners with stakeholders, teams, and external suppliers to implement innovative solutions and continuous improvements with demonstrated and measurable business results.

The suppliers and materials managed are utilized in products of multiple regulatory classifications (Drug Products, Cosmetics, NDAs, Class I Medical Devices, Nutritional Products, and Combination Products) and may include Chemicals, APIs, Packaging, and/or Fiber/Non-Wovens. The Materials Quality Lead ensures compliance with processes, controls, and standards for supplier and material quality management, following Kenvue policies and relevant regulations. (eg. 21 CFR 210 & 211, 21 CFR 820, and 21 CFR Part 11, EFfCI, and ICH Q7). As an integral member of project teams, the Materials Quality Lead ensures compliance and quality requirements are met for new and modified raw materials and packaging components.

Key Responsibilities

Material Quality Lifecycle Management:

o Responsible for the Quality review and approval of raw material and packaging change controls
o Acts as the Quality SME for material change controls and specifications through engagement with Kenvue Quality teams, Kenvue technical functions (Raw Material Center, Packaging Material Center, Analytical), Procurement, Suppliers, and/or others.
o Participates in the development of change control strategies for individual material changes and project related strategies for new materials and changes to existing materials.
o Ensure that material change control documentation is written well, matches the complexity of the change, meets Kenvue requirements, and is ready for regulatory inspection review.
o Work with the Manager, Material Quality and other teams to prioritize and complete numerous material changes and projects, successfully meeting department goals.
o Participate in projects with responsibility and accountability in support of North America regional objectives.

Material Quality Regional Strategy and Deployment:

o Integrates MQ activities within Supplier Quality's regional objectives in support of improving material and supplier reliability.
o Partners closely with Kenvue manufacturing sites to identify supplier/material issues impacting performance.
o Develops material quality strategies to ensure appropriate Critical to Quality/Critical to Process attributes are defined within specifications, or other relevant documents.

Material Quality Subject Matter Expert:

o Support the Raw Material and Packaging centers of excellence, providing the "Voice of Quality" for material selection, qualification, specifications, and controls.
o Attends relevant seminars and/or training events to maintain currency in Pharmaceutical Change Control practices and related GMP regulations.

Regional Supplier Quality activities:

o Performs other activities in support of regional Supplier Quality objectives.
o As necessary, acts as an independent reviewer or approver of non-conformance or other documentation.
o May be trained as a qualified auditor, to assist in the assessment of supplier performance

What we are looking for

Required Qualifications
o A minimum of a Bachelor's degree in a technical field (Engineering, Sciences, or similar disciplines) is required.
o A minimum of 6 years of GMP experience in either Pharmaceutical, Medical Device Manufacturing, OTC Drug, Cosmetic, and/or Food and Dietary Supplements production.
o Experience in a Technical or Quality Assurance function is required.

Desired Qualifications
o Knowledge of GMP requirements (21 CFR parts 210/211 or 820) and current FDA enforcement regulations is required
o Participate in cross-functional teams, build collaborative relationships with key-stakeholders, timely escalation of issues/roadblocks to management,
o Demonstrated ability to assess/mitigate risk and manage complex issues autonomously.
o Knowledge of the principles and practices of quality assurance in the consumer health, pharmaceutical, or medical device industry is required.
o Experience with Supplier Quality & Change Management is preferred.

What's in it for you

Annual base salary for new hires in this position ranges from 92K-149,500K. 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 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 business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or any other legally protected characteristic, and will not be discriminated against on the basis of disability.

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