Commercial Operations Quality Lead

Johnson & Johnson

. Serve as the primary quality representative supporting the Field Sales Network .

Posted 10/7/2026full-timeWest Chester • Pennsylvania • United StatesSenior💰 $63,000 - $101,430 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality management, compliance, and regulatory standards within the Field Sales Network, with a strong focus on audit preparation, CAPA management, and stakeholder collaboration. Proficient in developing training materials and promoting a culture of quality and continuous improvement.

Highest-signal resume keywords

Quality ManagementCAPA ManagementAudit PreparationRegulatory ComplianceStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsAudit CoordinationEffectiveness MonitoringSOP DevelopmentRisk ManagementChange ControlComplaint HandlingProject ManagementInventory ManagementContinuous Improvement

Soft Skills

Excellent CommunicationPresentation AbilitiesCoaching SkillsInfluencing StakeholdersTeam Collaboration

Tools & Technologies

EtQWindchillSAPMove MedicalPower BI

Certifications & Qualifications

ASQ CertificationLean/Six Sigma Certification

Industry Keywords

Medical DevicePharmaceuticalHealthcareRegulated IndustryGood Documentation Practices

About the role

Key responsibilities & impact

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 Field Sales Network 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 Field Sales Network management on inspection readiness and audit best practices
Support audit response activities and corrective action execution
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
Author, revise, review, and approve SOPs, work instructions, training materials, and operational procedures
Maintain process documentation supporting Field Sales Network operations, inventory management, facilities compliance, inbound/outbound processing, inventory controls, and quality systems
Partner with Operations Excellence to standardize practices across all Field Sales Network sites
Coordinate field actions, recalls, quarantines, and stop shipment activities across the Field Sales 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
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
Partner with Field Sales Network 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

Requirements

What you’ll need

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%
Preferred: Medical device, pharmaceutical, healthcare, or regulated industry experience
Preferred: Experience supporting audits and regulatory inspections
Preferred: Knowledge of Good Documentation Practices (GDP), CAPA, complaint handling, change control, and risk management
Preferred: Experience with quality systems such as EtQ, Windchill, SAP, Move Medical, Power BI, or similar platforms
Preferred: ASQ certification, Lean/Six Sigma certification, or equivalent quality credentials

Benefits

Comp & perks

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Additional general Company benefits information available at careers.jnj.com/employee-benefits
Remote work options may be considered on a case-by-case basis and if approved by the Company