Global Product Quality Reporting Process Owner

Johnson Johnson; Titusville (NJ); On-site; USD 120,000 - 180,000; Full time

Job summary

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to lead end-to-end BPDR, FAR, APR, and PQR processes within Innovative Medicine Quality. This role will coordinate with sites in Titusville, NJ; Raritan, NJ; and Horsham, PA, guiding governance and data-driven quality initiatives across a global matrix.

You will drive standardization, analytics, and compliance, partnering with Regulatory, Quality, and platform teams to ensure robust product quality governance.

Responsibilities

• Global process ownership: Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle for IM.
• BPDR/FAR governance and filing decisions: Provide global process leadership for BPDR and FAR with governance and decision framework.
• APR/PQR governance: Act as the global process owner for the end-to-end Product Quality Review / APR/PQR process.
• Integrated product-quality insight: Connect signals across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA and more to identify risks.
• Standardization and simplification: Drive a globally consistent framework and simplify workflows and handoffs across sites and functions.
• Metrics, management review, and effectiveness: Define and analyze KPIs and quality metrics for governance forums.
• Digital, data, and analytics enablement: Own data governance and requirements for enabling systems, analytics, and reporting.

Job description

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to lead end-to-end BPDR, FAR, APR, and PQR processes within Innovative Medicine Quality. This role will coordinate with sites in Titusville, NJ; Raritan, NJ; and Horsham, PA, guiding governance and data-driven quality initiatives across a global matrix.

You will drive standardization, analytics, and compliance, partnering with Regulatory, Quality, and platform teams to ensure robust product quality governance.