Major Accountabilities

• Process Governance & Standardization: Establish and oversee robust clinical process governance frameworks, including management of process forums, SOP systems, and standardized templates to ensure consistency and efficiency across clinical operations.
• Quality System Management: Lead the development, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring alignment with regulatory requirements and organizational standards.
• Documentation & Knowledge Management: Ensure effective management of clinical documentation, including SOP master lists, eTMF templates, SharePoint systems, and archival processes, to support compliance, traceability, and accessibility.
• Regulatory Intelligence & Compliance Oversight: Drive regulatory intelligence gathering and assessment, translating insights into actionable process improvements and ensuring ongoing compliance with evolving regulations.
• Training & Capability Building: Oversee clinical training strategy and delivery (including GCP and process training), ensuring workforce capability,



compliance, and continuous skill development.
• Audit, Inspection & Continuous Improvement: Lead/ support internal audits (as per assignment), self-inspections, and quality investigations (including CAPA coordination), driving remediation actions and embedding a culture of continuous improvement and inspection readiness.
• Cross-functional Collaboration & Operational Support: Partner with Legal, Data Privacy, Medical Affairs, and other stakeholders to ensure integrated process execution, while supporting key administrative and operational activities such as onboarding, organizational governance, and system transitions.

Minimum Requirements

Work Experience:

• 13+ years pharmaceutical industry clinical experience in Development and Clinical Operations
• Excellent leadership, communication (written/verbal), stakeholders’ management and collaboration skills
• Excellent organizational skil

📌 Director Clinical Process Excellence (India)
🏢 Sandoz India
📍 India