Global Process Owner, PQ Reporting
Johnson & Johnson
Johnson & Johnson seeks a Global Process Owner for Product Quality Reporting in Schaffhausen, Switzerland. This role provides end-to-end ownership of biological product deviation reporting, field alert reporting, annual product reviews, and product quality reviews across the Innovative Medicine organization, establishing governance frameworks and driving compliant execution globally.
Responsibilities
- Own and establish governance frameworks for BPDR, FAR, APR, and PQR processes across Innovative Medicine
- Serve as ultimate filing decision authority for biological product deviation and field alert reporting assessments
- Define process KPIs, quality metrics, and analytics to monitor execution and compliance effectiveness
- Lead global community of practice and capability building across dispersed process owners and sites
- Drive digital enablement and data governance improvements with technology and quality innovation teams
Requirements
- Extensive experience in pharmaceutical quality, regulatory reporting, or product lifecycle management
- Demonstrated expertise in process governance, standardization, and end-to-end process architecture
- Strong knowledge of biological product deviation reporting, field alert reporting, and product quality review processes
- Proficiency with quality systems, data analytics, and digital enablement in regulated environments
- Proven ability to lead matrix teams and influence across functions without direct authority
- Understanding of FDA and international regulatory requirements for pharmaceutical products
Die Stellenanzeige wurde vor Vor 5 Tagen veröffentlicht
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