Senior Manager Post-Market Surveillance

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Quality

Customer/Commercial Quality

People Leader

Cincinnati, Ohio, United States of America, Danvers, Massachusetts, United States of America, Irvine, California, United States of America, Raritan, New Jersey, United States of America

Johnson & Johnson is currently recruiting for a Senior Manager Post-Market Surveillance! This position can be located in Cincinnati, OH, Danvers, MA, Irvine, CA or Raritan, NJ.

Accountable for the end-to-end design, performance and advancement of a defined global Post Market Surveillance processes. This role owns the process strategy, translation of business requirements into technical solutions, including accountability for governance of vendor-supported complaint and post-market quality services.

The Senior Manager, Post-Market Surveillance Governance is responsible for the global governance, effectiveness, and continuous improvement of Med Tech Post-Market Surveillance processes, systems, data, analytics, and reporting. The role leads the enterprise Post-Market Surveillance operating model across Med Tech Business Units, ensuring regulatory readiness, consistent execution, data integrity, timely signal detection, and delivery of Post-Market Surveillance plans, reports, and related regulatory documentation.

This leader will be responsible for the Business technical systems requirements & delivery for all quality system applications and digital solutions to support process execution. The role also provides governance and operational oversight for vendors supporting complaint management, Post-Market Surveillance, analytics, and related post-market quality services. This accountability includes translating quality and business requirements into supplier expectations, monitoring service, quality, compliance, capacity, and cost performance, and driving timely escalation, corrective action, and value creation.

The position partners across franchises, Medical Safety, Regulatory, Clinical, Engineering, Quality, Global Services, Procurement, Finance, Information Technology, and external suppliers to deliver compliant, scalable, efficient, and insight-driven post-market outcomes.

• Provide global governance for Post-Market Surveillance procedures, systems, data, analytics, and reporting, including strategic planning and impact assessments for emerging regulations, standards, and health authority expectations.
• Lead the Med Tech Post-Market Surveillance operating model across franchises, promoting consistent, scalable, and risk-based execution for complaint trending, signal detection, Post-Market Surveillance plans, Post-Market Surveillance reports, and related regulatory documentation.
• Interpret Post-Market Surveillance requirements and translate them into practical policies, procedures, systems, controls, training, and implementation plans that support patient safety, regulatory compliance, proactive risk management, and cost efficiency.
• Oversee methods for identifying, analyzing, evaluating, documenting, and escalating potential product signals, including complaint-rate trends, adverse-event rates, part usage, and other product-performance indicators.
• Support data scientists and other assigned team members in developing, maintaining, and advancing analytical methods, algorithms, digital tools, systems, and responsible artificial intelligence capabilities used by Post-Market Surveillance and vigilance teams.
• Ensure appropriate governance of data quality, analytical methods, statistical rationales, validation, documentation, change control, and technology sustainability.
• Drive continuous…