Global Product Quality Reporting Lead

Johnson & Johnson Co.

Beerse

On-site

EUR 150,000 - 210,000

Full time

9 days ago

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Job summary

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to join our Innovative Medicine Quality organization, located in Beerse, Belgium or Cork, Ireland. The role provides end-to-end ownership of BPDR, FAR, APR and PQR processes within a global matrix, aligning regulatory reporting, data governance, and quality governance across the product lifecycle.

You will drive a unified process framework, define KPIs, and partner with sites, Platform Quality, Regulatory, and

Responsibilities

  • Global process ownership for end-to-end BPDR/FAR and APR/PQR; establish scope, decision rights and lifecycle governance.
  • Provide governance for BPDR and FAR, including filing decisions and escalation pathways.
  • Act as global process owner for APR/PQR, guiding data gathering, trend interpretation and improvement follow-through.
  • Link signals across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA and other inputs for proactive risk management.
  • Drive a single, globally consistent framework, with clear controls for local or regulatory variation.
  • Define and analyze process KPIs and quality metrics for leadership review and governance forums.
  • Own requirements and data governance for enabling systems; partner on a coherent digital Quality ecosystem.
  • Lead the global Community of Practice and build process capability through guidance and training.
  • Ensure inspection readiness and translate insights into sustainable improvements; support audits.
  • Monitor performance and drive risk-based continuous improvement; foster stakeholder alignment across functions.

Job description

Johnson & Johnson is seeking a Global Process Owner for Product Quality Reporting to join our Innovative Medicine Quality organization, located in Beerse, Belgium or Cork, Ireland. The role provides end-to-end ownership of BPDR, FAR, APR and PQR processes within a global matrix, aligning regulatory reporting, data governance, and quality governance across the product lifecycle.

You will drive a unified process framework, define KPIs, and partner with sites, Platform Quality, Regulatory, and

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