Global Process Owner – Product Quality Reporting

Biopharma Careers; Antwerpen; Hybrid; EUR 120,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Global Process Owner (GPO) for Product Quality Reporting to join the Innovative Medicine Quality organization, located in Beerse, Belgium or Cork, Ireland. The role leads end-to-end BPDR/FAR and APR/PQR, connects regulatory data, and drives a standardized, risk-based quality framework across global sites.

The GPO will partner with regulatory compliance, platform quality, and site teams to ensure inspection readiness and drive continuous improvement through data

Qualifications

• Bachelor's degree required; degrees in related fields preferred.
• At least 12 years of relevant experience in regulated industry with QA and/or regulatory compliance.
• Knowledge of global GxP and cGMP requirements and translating them into sustainable global processes and controls.

Responsibilities

• Own the end-to-end BPDR/FAR and APR/PQR process architecture, governance, standards, and lifecycle.
• Provide global process leadership for BPDR and FAR, establishing governance and decision framework.
• Act as global process owner for APR/PQR, directing sustainable global execution and data interpretation.
• Connect signals across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA, and more to strengthen risk management.
• Drive one globally consistent process framework with justified local variation and clear handoffs.
• Define and analyze process KPIs and quality metrics for management review.
• Own data governance for enabling systems, analytics, and reporting in quality.
• Lead global Community of Practice and drive process capability through guidance and learning.

Skills

Global process ownership

Education

Bachelor's degree

Job description

Johnson & Johnson is seeking a Global Process Owner (GPO) for Product Quality Reporting to join the Innovative Medicine Quality organization, located in Beerse, Belgium or Cork, Ireland. The role leads end-to-end BPDR/FAR and APR/PQR, connects regulatory data, and drives a standardized, risk-based quality framework across global sites.

The GPO will partner with regulatory compliance, platform quality, and site teams to ensure inspection readiness and drive continuous improvement through data