Job Description
JOB DESCRIPTION
Role Purpose
Provide enterprise ownership for manufacturing CSV practices across the organization, ensuring globally consistent, compliant, and efficient processes in a regulated pharmaceutical environment.
Scope of Responsibility (Enterprise-Level)
• Multi-site, multi-market operations
• GxP and non-GxP processes with clear risk segregation
Key Responsibilities
Enterprise CSV & Compliance Leadership
• Own the enterprise CSV strategy for all manufacturing equipment in SUN Global Operations (drug formulations)
• Ensure a risk-based, inspection-ready validation model aligned with global regulatory expectations (FDA, EMA, MHRA, WHO, etc.).
• Govern validation standards, templates, and approaches across regions to prevent local over-validation and inconsistency.
• Serve as the primary senior SME during global reg...