Global Process Owner, PQ Reporting
Johnson & Johnson
Johnson & Johnson seeks a Global Process Owner for Product Quality Reporting in Beerse, Belgium, to establish governance and strategic direction for biological product deviation reporting, field alert reporting, annual product reviews, and product quality reviews across the Innovative Medicine organization.
Responsibilities
- Establish and maintain end-to-end process architecture, governance standards, and lifecycle management for BPDR, FAR, APR, and PQR
- Provide global leadership for filing decisions and ensure timely, consistent, compliant assessments and regulatory submissions
- Drive standardization of processes across sites while accommodating justified local and regulatory variations
- Define, monitor, and analyze process KPIs and quality metrics for management review and governance forums
- Lead the global Community of Practice to build capability, facilitate knowledge sharing, and drive adoption of process and technology changes
Requirements
- End-to-end process ownership experience in pharmaceutical quality or regulatory reporting
- Knowledge of BPDR, FAR, APR, and PQR processes or similar quality systems
- Experience with governance frameworks, decision rights, and quality compliance standards
- Capability to lead matrix organizations and influence across functions globally
- Expertise in data governance, metrics definition, and quality analytics
- Familiarity with digital quality systems, automation, and inspection readiness
L'offre d'emploi a été publiée il y a 1 jour
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