PV Operations Transformation Lead

Iqvia Biotech

8 - 13 years

15 - 19 Lacs

thane

Posted:2 weeks ago| Platform:

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Skills Required

automation data analysis kaizen analytical pharma process improvement clinical research healthcare black belt auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Strategically support PV Operations management in planning and implementing Lean Six Sigma (LSS) methodologies to drive operational excellence.
Lead transformation initiatives across PV Operations, including adverse event reporting, case handling, aggregate reporting, literature surveillance, and safety systems.
Develop and execute long-term process improvement roadmaps aligned with safety database capabilities and regulatory expectations.
Identify and lead key improvement projects that enhance quality, reduce costs, and improve productivity.
Apply LSS tools (e. g. , DMAIC, Kaizen, Value Stream Mapping) to streamline processes and standardize SOPs, process maps, and best practices to ensure GVP/GCP compliance.
Define, monitor, and report KPIs and quality metrics; develop dashboards to track performance trends and identify improvement opportunities.
Recommend and support automation and technology enhancements to optimize PV operations.
Champion a culture of continuous improvement and serve as a change agent to challenge existing processes.
Facilitate training sessions and workshops to build Lean Six Sigma capability, including coaching and certifying belted associates.
Collaborate with global PV teams, regulatory affairs, clinical operations, and external vendors to harmonize processes and ensure audit readiness.
Support CAPA implementation using Six Sigma problem-solving frameworks.
Provide strategic input and influence to senior leadership for PV transformation planning and execution.
Communicate data-driven insights to support improvement opportunities and stakeholder engagement.
Ensure alignment with organizational mission, standards, and guidelines through coordinated leadership support.
Perform other duties as assigned to support the organization s vision, mission, and values.

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