Manager, Commercial Quality – Global Labeling and IFU

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $102k - $177.1k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare • Pharmaceuticals • Biotechnology

<Johnson & Johnson> is a global healthcare company that researches, develops, manufactures and markets pharmaceuticals, medical devices and consumer health products. The company focuses on innovative medicines and therapies across oncology, immunology, neuroscience and cardiopulmonary areas, and develops MedTech solutions in cardiovascular, orthopaedics, surgery and vision. Johnson & Johnson also engages in health & wellness education, large-scale manufacturing, investor activities and global social-impact initiatives.

📋 Description

• Lead end-to-end improvements of global labeling processes across business-unit practices, country-specific label design, application, and execution • Ensure compliance and operational excellence across Distribution Centers and third-party logistics partners • Influence and guide a team supporting regional supply chain labeling systems and Instructions for Use • Maintain audit readiness and compliance with emerging labeling-customization regulations • Protect the right to sell medical devices at the country level • Act as strategic interface between Supply Chain, Deliver Functions, Regulatory Affairs, and Commercial Quality • Provide day-to-day operational support and drive changes for new product introductions, product transfers, and regional regulatory updates • Establish end-to-end Global Labeling processes and systems with cross-functional partners • Support Right Stage Customization and Repack Relabel Power App sustainability • Implement and sustain the global electronic IFU deployment process • Serve as Commercial Quality point of contact for Right Stage Customization governance • Troubleshoot and facilitate investigations with Deliver sites and key stakeholders • Monitor NC, CAPA, and escalation trends to continuously improve processes • Develop and implement innovation strategies involving advanced analytics, artificial intelligence, digital products, and supply chain solutions • Maintain regional connections, share improvements and trends, gather stakeholder and customer insights, incorporate emerging regulations, and maintain global standardization • Execute activities under GxP and ensure ongoing audit readiness

🎯 Requirements

• Bachelor’s degree required in Engineering, Life Sciences, Regulatory Affairs, or related field • 6+ years of experience in Quality, Regulatory Affairs, or Compliance within a medical device and/or regulated healthcare environment • Labeling and/or experience in last mile operations • Strong planning, project management, risk management, and change management expertise • Strong working knowledge of global medical device labeling regulations and standards, including FDA, EU MDR, and ISO 13485 • Process Excellence (Lean, Six Sigma) experience across diversified business areas or equivalent quality standards programs • Ability to execute work in a highly matrixed, cross-functional, and often ambiguous environment • Experience with Microsoft Power Apps • Demonstrated track record of process improvements, turnaround, and transformations • Excellent decision-making and problem-solving skills • Team building, influencing, and development capabilities • English required • ASQ, PMP, or similar certifications preferred but not required • Up to 25% domestic and international travel

🏖️ Benefits

• Retirement plan (pension) • 401(k) savings plan • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; Colorado employees – 48 hours; Washington employees – 56 hours • 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 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 • Fully remote work • Limited travel; up to 25%, domestic and international