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

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

• Lead end-to-end improvements of global labeling processes, including 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 • Act as the strategic interface between Supply Chain, Deliver Functions, Regulatory Affairs, and Commercial Quality • Provide day-to-day operational support and drive changes related to new product introductions, product transfers, and regional regulatory updates • Establish end-to-end Global Labeling processes and systems with Regulatory Affairs, Supply Chain, Q&C, and Deliver functions • Support sustainability of the Right Stage Customization system and processes • Support sustainability of the Repack Relabel Power App • Implement and sustain the global DePuy Synthes electronic IFU deployment process • Serve as Commercial Quality point of contact for Right Stage Customization governance • Troubleshoot and solve problems for Deliver sites, facilitating investigations and stakeholder connections • Monitor process improvements through NC, CAPA, and escalation trends, using root-cause findings for continuous improvement • Develop and implement innovation strategies involving advanced analytics, artificial intelligence, digital products, and supply chain solutions • Collaborate with regions to share improvements and trends, gather business 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, 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 • Up to 25% domestic and international travel • ASQ, PMP, or similar certifications preferred but not required

🏖️ Benefits

• Retirement plan (pension) • Savings plan (401(k)) • Vacation – 120 hours per calendar year • Sick time – 40 hours per calendar year; 48 hours for Colorado employees; 56 hours for Washington employees • 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