Commercial Operations Lead

Johnson & Johnson

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

Posted 10/7/2026full-timeRemote • 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 medical device and pharmaceutical industries. Proficient in leading audits, managing CAPAs, and developing quality training programs to ensure operational excellence.

Highest-signal resume keywords

Quality ManagementAudit PreparationCAPA ManagementRegulatory ComplianceStakeholder Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality SystemsGood Documentation PracticesChange ControlRisk ManagementProject Management

Soft Skills

Excellent CommunicationPresentation AbilitiesCoaching Skills

Tools & Technologies

EtQWindchillSAPMove MedicalPower BI

Certifications & Qualifications

ASQ CertificationLean/Six Sigma Certification

Industry Keywords

Medical DevicePharmaceuticalHealthcareRegulated IndustryCompliance Assessments

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
Lead audit preparation activities and 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
Drive investigation, remediation, and closure of quality observations
Develop sustainable corrective and preventive actions with cross-functional teams
Monitor aging metrics and effectiveness monitoring activities
Author, revise, review, and approve SOPs, work instructions, training materials, and operational procedures
Standardize practices across FSN sites with Operations Excellence
Coordinate field actions, recalls, quarantines, and stop shipment activities
Assess inventory impacts and maintain stop shipment governance and reporting
Monitor quality training compliance and deliver training on quality procedures and operational standards
Promote quality, inspection readiness, and continuous improvement
Partner with FSN leadership, Site Leads, Commercial Quality, Facilities, Supply Chain, Systems, and Franchise Quality teams
Consult 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%
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 EtQ, Windchill, SAP, Move Medical, Power BI, or similar platforms preferred
ASQ certification, Lean/Six Sigma certification, or equivalent quality credentials preferred

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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Inclusive interview process and disability accommodations
Equal opportunity employment