Specification Lead
Kenvue NA

Kenvue is currently recruiting for:

Specification Lead

This position reports to Senior Manager Make Quality and is based at Fort Washington, PA

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: Senior Manager Make Quality

Location: Fort Washington, PA

Travel %: 10

What you will do

The Specification Lead will work with cross-functional areas to ensure that the ICH guidelines, GMP, FDA guidance, Pharmacopeia, Industry standards, standard operating procedures (SOPs) are followed/ implemented.

Key Responsibilities

• Maintain the lifecycle of the finished products specifications/test methods and raw material specifications/test methods.

• Partner with R&D/ Procurement/ Change Control/EMQA and the Internal Manufacturing Sites to increase efficiency of finished products specifications /test methods and raw materials specifications/ test methods process.

• Lead meetings regularly with R&D, Regulatory Affairs, PSJ Primary members to discuss the projects strategies for the FDA submissions

• Simplify processes, requirements and procedural instructions/Review PSJ and specifications/ test methods SOPs to minimize redundance.

• Approve documentation of commercial raw material and finished products specifications and test methods as the final QA approver.

• Provide support for the raw material and finished products specifications APR contributions for the Internal Manufacturing and External Manufacturing sites.

• Lead the Product Specification Justification (PSJ) process and objectives

• Attend the US Self Care Compendium forum for specifications and test methods compendium change implementation.

• Identify the specifications/ test methods implementation strategies to meet the requirements of Canada, EMEA, USP, Pharmacopoeia, internal and EM sites requirements.

• Collect QA metrics on the specifications/ test methods process performance/ Enhance QA metrics.

• Support R&D to gain efficiency in specifications/test methods revisions update cycle time

What we are looking for

Required Qualifications

• A minimum of a Bachelor's degree or higher is required; degree concentration in Chemistry, Life Science, Physical Science or related preferred.

• A minimum of six (6) years of relevant experience in the Consumer/OTC/pharmaceutical industry

• Expert Knowledge of cGMP, USP, ICH requirements and current FDA issues

• Experience with specifications and Analytical test methods

• Experience working on cross-functional project teams

• Detailed understanding of site quality activities (change control, deviation investigations, APR review, product release)

• Ability to effectively Lead Quality issues and drive resolution

• Develop relationships and influence others in a remote environment

• Work independently on complex issues; serve as a subject matter / technical specialist within the functional area

• Strong leadership and project management skills and abilities

• Analytical, prioritization, and communication skills. The ability to communicate with all levels of the organization is essential

Desired Qualifications

• Experience in a Quality Assurance role

• Experience working with Analytical R&D and internal/external manufacturing sites

• Experience working in Analytical laboratories

What's in it for you

• 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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