Quality Lead, Commercial Ops (Remote-Eligible)

Johnson & Johnson MedTech; West Chester (Chester County); On-site; USD 63,000 - 101,000; Full time

Job summary

Johnson & Johnson is seeking a Commercial Operations Quality Lead in West Chester, PA to partner across FSN, ensuring compliance with quality systems and regulatory standards. This role drives CAPAs, audits, training, and continuous improvement in a national field inventory network.

The ideal candidate will have 5+ years in quality or regulatory roles, strong PM and communication skills, and the ability to travel 25–40% to support audit readiness and CAPA execution across sites.

Qualifications

• Bachelor's degree in Engineering, Quality, Life Sciences, Supply Chain, Business, or related field.
• 5+ years of experience in Quality, Operations, Regulatory, Compliance, Supply Chain, or Medical Device environments.
• Experience managing CAPAs, audits, investigations, observations, or quality systems.
• Strong project management and stakeholder management skills.
• Excellent communication and presentation abilities.
• Ability to travel approximately 25-40%.

Responsibilities

• 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.
• Lead audit preparation activities for FSN locations and coordinate inspections.
• 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.
• Drive investigation, remediation, and closure of quality observations with cross-functional teams.
• Author, revise, review SOPs, work instructions, training materials, and procedures.
• Coordinate field actions, recalls, quarantines, and stop shipment activities.

Skills

Project management

Stakeholder management

Communication

Presentation

Education

Bachelor's degree in Engineering, Quality, Life Sciences, Supply Chain, Business, or related field

Tools

EtQ

Windchill

SAP

Move Medical

Power BI

Job description

Johnson & Johnson is seeking a Commercial Operations Quality Lead in West Chester, PA to partner across FSN, ensuring compliance with quality systems and regulatory standards. This role drives CAPAs, audits, training, and continuous improvement in a national field inventory network.

The ideal candidate will have 5+ years in quality or regulatory roles, strong PM and communication skills, and the ability to travel 25–40% to support audit readiness and CAPA execution across sites.