Role reports to:Commercial Quality Sr Manager NA
Location:North America, United States, New Jersey, Summit
Work Location:Hybrid
What you will doWhat you will doThe Staff Quality Specialist, Commercial Quality provides regional quality support for commercial, transportation, and customer service operations across North America. This role helps ensure that operations comply with company quality systems, regulatory requirements, and current Good Manufacturing Practices (cGMPs).
The position partners with Deliver, regional operations, Make Quality, Distribution Center Quality, and other cross-functional teams to strengthen quality controls, improve service models, reduce nonconformances, and support reliable delivery of quality products through our supply chain and to consumers on time and in full.
Responsibilities- Support the development, implementation, and maintenance of processes and controls for commercial and transportation operations in accordance with company policies, procedures, global quality systems, applicable regulations, and cGMPs.
- Lead regional improvement strategies, including the development, implementation, and optimization of quality service models.
- Support Regional Quality Objectives by helping define measures, monitoring progress, and presenting quality performance through metrics, scorecards, and quality reviews with Deliver Operations.
- Ensure compliant regional execution of transportation lane-mapping studies, transportation mode qualifications, and transportation temperature-control and monitoring systems.
- Provide supplier quality support for transportation and temperature-control suppliers in accordance with applicable purchasing-control procedures.
- Lead reviews of transportation-related temperature excursions and assess potential product-quality impact.
- Partner with Internal and External Manufacturing Quality, Distribution Center Quality, Deliver, Customer Service, and other business teams to resolve quality issues and improve processes.
- Lead or participate in product and process risk assessments.
- Ensure Non-Conformances and CAPAs related to commercial and transportation operations are initiated, assigned, investigated, documented, completed, and checked for effective resolution.
- Implement projects that reduce nonconformances, improve cycle times, increase efficiency, and support cost-improvement objectives without compromising quality or compliance.
- Educate business partners on quality-system requirements and their effect on product quality and regulatory compliance.
- Represent Quality in cross-functional projects, governance meetings, process-improvement work, and innovation initiatives.
- Support audit and inspection readiness and participate in audits or regulatory inspections as assigned.
- Balance competing priorities, address time-sensitive quality issues, and support the development of colleagues through coaching and knowledge sharing.
What we are looking forRequired Qualifications- Bachelor's degree.
- 6-8 years of relevant business experience in an FDA- or Health Canada-regulated industry.
- Experience in Quality Assurance, Quality Systems, Supply Chain, or Transportation Operations.
- Working knowledge of cGMP requirements applicable to one or more regulated product categories, including cosmetics, over-the-counter products, OTC monograph products, or medical devices.
- Experience leading complex or strategic projects.
- Experience with investigations, root-cause analysis, CAPA, risk assessment, and quality documentation.
- Strong written, verbal, presentation, and interpersonal communication skills.
- Ability to work across organizational boundaries and influence outcomes in a matrix environment, with or without direct authority.
- Ability to analyze complex issues, set priorities, and drive work to completion.
Desired Qualifications- Advanced degree in a relevant scientific, engineering, quality, or business discipline.
- ASQ or project-management certification.
- Experience conducting or hosting audits and regulatory inspections.
- Experience with continuous-improvement methods.
- Experience with transportation quality, temperature-control systems, lane-mapping studies, transportation mode qualification, or supplier quality management.
- Experience using quality metrics, scorecards, and trend analysis to guide decisions and communicate performance.
- Experience coaching or mentoring colleagues.
Travel: Up to 10%
People leadership: May oversee 0 to 1 contractor or other direct/indirect resource
What's in it for youAnnual base salary for new hires in this position ranges:
$110,500.00 - $156,000.00
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.
