Global Process Owner: Product Quality Reporting

6010-Biosense Webster Inc. Legal Entity; Belgique; On-site; EUR 119,000 - 204,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson seeks a Global Process Owner for BPDR, FAR, APR and PQR in Beerse, Belgium or Cork, Ireland. You will own end-to-end process architecture and governance for regulatory reporting, product reviews, and quality governance across the product lifecycle.

You will collaborate with sites, regulatory, and technology teams to drive standardization, data governance, and continuous improvement while building a global network of process owners and ensuring inspection readiness.

Qualifications

• Minimum of a Bachelor's degree is required.
• Degrees in science or engineering or related discipline preferred.
• Experience in pharmaceutical/regulated industry is advantageous.

Responsibilities

• Own BPDR/FAR and APR/PQR process architecture and governance.
• Provide global process leadership for BPDR and FAR filings.
• Lead APR/PQR governance and end-to-end execution.
• Connect data and insights across BPDR/FAR, APR/PQR, complaints, investigations, NC/CAPA.
• Drive standardization, digital enablement, and global process improvements.
• Define KPIs and management-review reporting for quality governance.
• Lead global Community of Practice and process-owner network.
• Ensure inspection readiness and respond to regulatory observations.

Skills

Business Process Management

Business Requirements Analysis

Compliance Management

Data Savvy

Decision Making

ISO 9001

Process Governance

Process Optimization

Stakeholder Engagement

SOP

Tactical Planning

Tactical Thinking

Technical Credibility

Education

Bachelor's degree in a related field

Job description

Johnson & Johnson seeks a Global Process Owner for BPDR, FAR, APR and PQR in Beerse, Belgium or Cork, Ireland. You will own end-to-end process architecture and governance for regulatory reporting, product reviews, and quality governance across the product lifecycle.

You will collaborate with sites, regulatory, and technology teams to drive standardization, data governance, and continuous improvement while building a global network of process owners and ensuring inspection readiness.