Computer System Validation Lead - NA

Kenvue Inc.; Summit, Northern (NJ, KY); Hybrid; USD 90,000 - 127,000; Full time

Benefits offered by this job

Competitive benefits

Paid holidays and vacation

Volunteer time

Learning & development opportunities

Kenvuer Impact Networks

Job summary

Kenvue Inc. is seeking a Computer System Validation Lead for North America (NA) to oversee validation/qualification of applications, infrastructure, and digital health solutions within the SDLC and CSV framework.

You will build quality into end-to-end lifecycle activities and support audits and inspections. The role partners across Technology Quality & Compliance to ensure regulatory readiness, develop validation documentation, and lead validation activities for systems within scope.

Qualifications

• Bachelor's degree or equivalent in Business, Marketing, Data Science, or a related field.
• 4 to 6 years of experience in customer success, value management, process validation, equipment qualification, or related quality assurance roles.
• Strong knowledge of industry regulations, validation policies, and quality systems.
• Proven ability to analyze technical problems and implement corrective actions.
• Experience in developing and reviewing validation and qualification documentation.
• Excellent communication skills for effective collaboration with cross-functional teams and external parties.

Responsibilities

• Engage with technology teams to involve TQ&C early in design and development, building quality into the work product and controls.
• Ensure company quality standards and regulatory requirements are met for systems under responsibility.
• Plan, execute, coordinate, and maintain validation activities including SDLC validation documentation and system changes.
• Review and approve SOPs and WI related to systems and assist with incident management/CAPA and NCs.
• Support internal audits and regulatory inspections.

Skills

Communication skills

Regulatory knowledge

Documentation skills

Problem solving

Education

Bachelor's degree or equivalent in Business, Marketing, Data Science, or related field

Job description

Computer System Validation Lead - NA

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. For more information.

Role reports to

Leader Tech Quality and Compliance

Location

North America, United States, New Jersey, Summit

Work Location

Hybrid

What you will do

Technology Quality and Compliance (TQ&C) manages the quality and compliance strategy for technology systems including applications, infrastructure, and digital health solutions. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with the company’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with addressing compliance gaps related to audits and inspections.

The Lead Computer Systems Validation Specialist (CSV) NA is responsible for the building and execution of quality into enterprise wide systems, tools, services, and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, and retire).

Roles and Responsibilities

• Engaging with technology team members ensuring early involvement of TQ&C in the design and development of applications and infrastructure, building quality into the work product, and controls within the application/solution while leveraging automation whenever feasible.
• Ensuring company quality standards and regulatory requirements are met for the systems under the scope of responsibility.
• Planning, executing, coordinating, and maintaining the validation activities for the systems within their scope, including approval of SDLC validation documentation, release system implementation, and/or changes for production use while providing computerized systems validation guidance and support to support team members in the execution of system base business activities, enhancements, and small projects.
• Reviewing and approving SOPs and WIs related to the systems within their scope and assisting with incident management/CAPA (Corrective and Preventative Action) and NCs for systems supported.
• Supporting internal audits, Health Authority regulatory inspections, and system periodic reviews.

What we are looking for

Required Qualifications

• Bachelor's degree or equivalent in Business, Marketing, Data Science, or a related field.
• 4 to 6 years of experience in customer success, value management, process validation, equipment qualification, or related quality assurance roles.
• Strong knowledge of industry regulations, validation policies, and quality systems.
• Proven ability to analyze technical problems and implement corrective actions.
• Experience in developing and reviewing validation and qualification documentation.
• Excellent communication skills for effective collaboration with cross-functional teams and external parties.

Desired Qualifications

• Proven expertise in leveraging analytics tools and CRM platforms to drive customer insights and strategic decision-making.
• Exceptional communication skills with the ability to translate complex data into compelling narratives for diverse stakeholders.
• Demonstrated leadership capabilities with a track record of mentoring teams and driving cross-functional collaboration.
• Capability to lead validation activities and represent the function during audits and inspections.
• A proactive mindset with a passion for innovation, continuously seeking novel approaches to enhance customer value and business growth.

What’s in it for you

Annual base salary for new hires in this position ranges:

$90,100.00 - $127,200.00

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

If you are an individual with a disability, please check our Disability Assistance page for information on how to request an accommodation.