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...