Commercial Operations Lead

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $63k - $101.4k / year

⏰ Full Time

🟠 Senior

⚙️ Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

🏥 Healthcare

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Healthcare • Healthcare Insurance • Pharmaceuticals

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• 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

• 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

• 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