Who We Are

At Kenvue, part of the Johnson & Johnson Family of Companies (Kenvue), we believe there is extraordinary power in everyday care. Built on over a century of heritage and propelled forward by science, our iconic brands—including NEUTROGENA®, AVEENO®, TYLENOL®, LISTERINE®, JOHNSON’S® and BAND-AID® —are category leaders trusted by millions of consumers who use our products to improve their daily lives. Our employees share a digital-first mindset, an approach to innovation grounded in deep human insights, and a commitment to continually earning a place for our products in consumers’ hearts and homes.

Join us in shaping our future-and yours.

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What will you do

The Quality Stability Manager is responsible for the Stability programs that support commercial production (MPS). You will manage a team of professionals all working towards the goals and expectations of Kenvue, the new consumer company. You will implementation strategies designed to lead cross-functional Compliance & Quality improvement initiatives within the Stability programs. Success is measured through outcomes and performance metrics related to the processes.

Key Responsibilities

• Serve as the Chairperson to the Stability Committee and the owner of the Stability Community of Practice providing overall Quality Assurance leadership.
• Partners with External Manufacturers, External Packagers, and Contract Laboratories which manufacture and/or perform stability testing on behalf of J&J Consumer to ensure that requirements are being met.
• Lead and support the Marketed Product Stability groups at EM Consumer NA and Self Care sites for their Marketed Product Stability (MPS) programs by providing direction and leadership to stability personnel within the group.
• Provide guidance and support to the Research & Development (R&D) Stability group for developmental stability programs on new products, technical transfers and change controls ensuring that expectations for market approval are incorporated into the stability strategies.
• Responsible for influencing development, approving, and then facilitating the execution of stability strategies across functional areas, internal and external sites (for both the R&D and MPS groups) based on regulatory requirements, internal procedures, technical information and historical stability data.
• Approve documentation of Master Stability Protocols, Study Specific Stability Protocols, Stability Plans, Stability Reports, statistical analysis of stability data and the Annual Stability Report (used for both the Annual Product Review and the Annual Report submission to the FDA).
• Provide communication to senior leadership on status of key initiative and issues.

People Managers

• Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
• Oversee staff to ensure:
  • correct use of statistical tools for trend monitoring and evaluation of EM Stability data,
  • procedures for data receipt/verification and statistical output interpretation, documentation, and review are followed,
  • review and approval of compliance records, specifications, procedures, and other documents, as required by procedure,
  • stability databases are maintained as appropriate.
• Promote an environment of employee involvement in the workplace and commitment to doing the job right the first time.
• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

Job Related Duties

• Maintain up to date knowledge of industry practices and compliance with cGMPs and ensure procedures are authored/revised in support of stability processes.
• Attend GMP training on the schedule designated for the role
• Adhere to strict compliance with procedures applicable to the role.
• Exercise the highest level of integrity in the tasks performed.

Required Qualifications

• Bachelor’s Degree in a technical field (Chemistry, Engineering, Sciences, Pharmacy or similar disciplines) required.
• A minimum of 8-10 years of professional experience in a regulated industry is required (Pharmaceutical, OTC Drug, Cosmetic, and/or Food and Dietary Supplements Industry).
• Experience in a Quality Assurance function.
• Experience in the execution of stability studies.
• Supervisory experience in an FDA-regulated industry.
• A minimum of 5 years Quality experience.
• Experience in the participation of internal and external audits and regulatory inspections
• Strong leadership and coaching skills are required and prior experience leading a team of quality professionals is required.

• Strong knowledge of 21 CFR 210 & 211 and ICH guidance is required.
• Strong communication (verbal, written, and presentation) and interpersonal skills, self-awareness and adaptability required.
• Knowledge of statistical techniques, ICH, FDA and other regulatory body of knowledge related to analytical/stability procedures is required.

Preferred Qualifications

• Detailed working knowledge of cGMP requirements and current FDA enforcement issues.
• Demonstrated ability to lead cross-functional teams and collaborate with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback.
• Ability to influencing with and without line authority.
• Demonstrated skills navigating within a matrix environment
• Results-oriented with strong track record of success in delivering on objectives.
• Theoretical and/or hands experience in applied analytical chemistry and related instrumentation such liquid and gas chromatography, FTIR/UV/Vis/NIR spectrometry and wet chemistry is required.
• Knowledge of method transfer, and validation requirements is necessary.

What’s in it for you

• Competitive Benefit Package
• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!
• Learning & Development Opportunities
• Employee Resource Groups

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.