Specialist, R&D Quality & Compliance

Kenvue • Summit, NJ

4d • Hybrid

About The Position

The Specialist, R&D Quality & Compliance administers integrated and comprehensive quality systems and controls to help ensure R&D functions operate in compliance with sound scientific practices, cGMP requirements, and company procedures. The role supports documentation review and approval, audits and inspections, archival activities, internal assessments, R&D study releases, and regulatory guidance. It serves as a Quality representative on R&D project teams and provides GMP training and procedural guidance to R&D personnel. The position is based in Summit, New Jersey, with a hybrid work location, and reports to the Sr Mngr RD Quality & Compliance.

Requirements

• Bachelor's degree in a relevant field or equivalent experience.
• 2–4 years of experience in a pharmaceutical, cosmetics, consumer products, or FDA-regulated environment.
• Experience working effectively in a team-based environment.
• Strong organizational skills.
• Strong communication, interpersonal, and facilitation skills, including verbal, written, and presentation skills.
• Expertise in handling multiple priorities.
• Strong experience using Microsoft Office applications, including Word, Excel, and PowerPoint.

Nice To Haves

• Product development process experience.
• Knowledge of cGMP/cGLP requirements for cosmetic, OTC, and medical device products.

Responsibilities

• Review and approve GMP documentation and batch records, including laboratory batches with process controls.
• Conduct quality inspections of supplies for R&D studies.
• Serve as the Quality representative on R&D project teams.
• Provide GMP regulatory guidance and training.
• Maintain GMP documentation, storage, and archival processes.
• Participate in GMP/Q&C procedure development, revision, and implementation, and support related process improvements.
• Perform internal assessments and support inspection readiness.
• Collect, compile, and report North America R&D Quality metrics across Kenvue sites monthly and semiannually.
• Support internal and GRC audit preparation and execution, including coordinating and gathering documentation for pre-audit requests.
• Manage non-marketed product quality complaints in accordance with applicable procedures.
• Assist in compiling documentation for R&D study release and inspection readiness activities.
• Provide additional training and procedural guidance to R&D personnel on Quality processes and GMP documentation.
• Identify and escalate quality and compliance gaps within assigned areas of responsibility.

Benefits

• Paid company holidays.
• Paid vacation.
• Volunteer time.
• Learning and development opportunities.
• Kenvuer Impact Networks.
• Competitive benefit package; specific benefits may vary by location or region.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level