Suresh John Kandavalli

Quality Manager Validation and Launch, Finished Goods Commercial @Vertex Pharmaceuticals

Lead Quality Commercial Finished Goods process validation activities • Lead Commercial Finished Goods product launch activities • Collaborate with hey business partners to develop launch and validation strategies • Develop relationships with strategic external partners in support of Vertex’s expanding commercial portfolio and manages ongoing relationships • Perform disposition activities for Finished Goods in support of Commercial Product, including: o Master and Executed Batch Record review and resolution of comments/issues o Evaluations of Investigations/ OOS/ Change Controls to support Disposition Status o Certificate of Analysis approval o Status change in Oracle o Aichiving of batch documents in electronic document system o Assist with Escalation and Material Review Board activities, when necessary • Lead quality oversight of artwork review, approval, & implementation for Commercial Finished Goods • Provide quality guidance for root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions ai’e identified • Provide compliance guidance to Commercial project teams • QP Relationship, including facilitation of QP Release of finished goods and QP Declaration requests • Perform Quality assessments and approvals for Commercial Change Control, ensure engagement of coiiect assessors on change type and provide strategy for product disposition • Assist in creating, negotiating, and maintaining Quality Agreements. • Assist with establishment of Quality Processes/Process Ownership — Packaging /Labe1ing and QP Release of Finished Goods • Monitors and trend events and identifies/proposes corrective actions. • May serve as CAPA owner. • Identifies risks and communicates gaps to management. • Generates and maintains operational batch release metrics for launch activities. • Support deployment of the Quality Management System as GMP Representative. • Provide Audit/inspection Support.