Specialist, R&D Quality & Compliance
Role reports to:Sr Mngr RD Quality & Compliance
Location:North America, United States, New Jersey, Summit
Work Location:Hybrid
What you will doWhat you will doThe Specialist, R&D Quality & Compliance (R&D Q&C) is responsible for administering integrated and comprehensive quality systems and controls to ensure R&D functions operate in compliance with sound scientific practices, cGMP requirements, and company procedures. Responsibilities include documentation review and approval, audits, inspections, archival activities, internal assessments, support of R&D study releases, and regulatory guidance.
Key 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 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 & semiannual).
- 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 & GMP documentation.
- Identify and escalate quality and compliance gaps with assigned areas of responsibility.
What we are looking forRequired Qualifications- Bachelor's degree in a relevant field or equivalent experience.
- Requires 2-4 Years in pharmaceutical, cosmetics, consumer products, or FDA-regulated environment.
- Experience with working effectively in a team-based environment.
- Strong Organizational Skills
- Strong Communication/Interpersonal and Facilitation Skills (verbal, written and presentation)
- Expertise in Handling Multiple Priorities
- Strong experience using the Microsoft Office suite of applications (Word, Excel, PowerPoint)
Desired Qualifications- Developing Product development process experience; knowledge of cGMP/cGLP requirements for cosmetic, OTC, and medical device products.
What's in it for youAnnual base salary for new hires in this position ranges:
$82,025.00 - $115,800.00
This takes into account a number of factors including work location, the candidate's skills, experience, education level & other job-related factors.
- 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.
