Commercial Operations - Quality Lead

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Sales Enablement Job Sub Function: Sales Operations & Administration Job Category: Business Enablement/Support All Job Posting Locations: Remote (US), West Chester, Pennsylvania, United States of America Job Description: About Orthopaedics Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that’s reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. We are searching for the best talent for the Commercial Operations - Quality Lead in West Chester, PA. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: Commercial Operations Quality Lead Global Distribution & Commercial Logistics (GDCL) - Field Sales Network Position Summary The Commercial Operations Quality Lead serves as the primary quality partner for the Field Sales Network (FSN), ensuring compliance with Johnson & Johnson quality systems, regulatory requirements, and internal standards across a national network of field inventory locations. This role partners closely with FSN leadership, site leads, Commercial Quality, Operations Excellence, Facilities, and business process teams to drive audit readiness, quality system compliance, process standardization, corrective and preventive actions (CAPAs), inspection management, field actions, stop shipments, training compliance, and continuous improvement initiatives. The ideal candidate combines strong quality and compliance expertise with operational leadership, influencing skills, and the ability to develop practical solutions in a dynamic field-based environment. You will be responsible for: Quality Systems & Compliance Serve as the primary quality representative supporting the Field Sales Network. Ensure compliance with internal quality requirements, SOPs, work instructions, and regulatory expectations. Maintain oversight of quality metrics, observations, CAPAs, effectiveness monitoring activities, and audit action plans. Partner with Commercial Quality to prioritize and close quality observations and compliance gaps. Audit & Inspection Readiness Lead audit preparation activities for FSN locations. Coordinate internal audits, ERC audits, JJIA audits, FDA inspections, and other compliance assessments. Develop audit preparation plans, opening presentations, readiness documentation, and site support materials. Coach site leaders and FSN management on inspection readiness and audit best practices. Support audit response activities and corrective action execution. CAPA & Observation Management Drive investigation, remediation, and closure of quality observations. Partner with cross-functional teams to develop sustainable corrective and preventive actions. Monitor aging metrics and ensure timely execution of commitments. Manage effectiveness monitoring activities and ongoing compliance assessments. Process Development & Documentation Author, revise, review, and approve SOPs, work instructions, training materials, and operational procedures. Maintain process documentation supporting FSN operations, inventory management, facilities compliance, inbound/outbound processing, inventory controls, and quality systems. Partner with Operations Excellence to standardize practices across all FSN sites. Field Actions, Recalls & Stop Shipment Management Coordinate field actions, recalls, quarantines, and stop shipment activities across the FSN network. Assess inventory impacts and partner with operations teams on execution plans. Maintain stop shipment governance processes and reporting. Serve as a key liaison between quality, operations, and franchise teams during product holds and recalls. Training & Quality Culture Monitor quality training compliance and support remediation of training gaps. Develop and deliver training on quality procedures, compliance requirements, and operational standards. Promote a culture of quality, inspection readiness, and continuous improvement throughout the FSN organization. Cross-Functional Partnership Partner with FSN leadership, Site Leads, Commercial Quality, Facilities, Supply Chain, Systems, and Franchise Quality teams. Provide consultation on operational changes, risk assessments, and quality impacts. Influence stakeholders to achieve compliant and practical business solutions. Qualifications / Requirement s: Required Bachelor's degree in Engineering, Qua