Global programme management of Biosimilar assets through development, filing, approval and post approval variations

Network Transformation & Technology Transfer- Led a strategic manufacturing network transformation program for a Global generics manufacturer to establish supply assurance and mitigate risk for high value/volume OSD products by developing robust back-up manufacturing sites. Established governance forums with clean decision rights and created comprehensive plans to drive the tech transfer activities to deliver milestones under a weak matrix environment and challenging timelinesProgram Management- Led the planning and tracking of activities involved in providing responses to queries put forth by a regulatory agency as part of the approval process for a biologic developed by a top Indian pharma company- Led a team of consultants in a Quality Control Transformation project, with focus on lab productivity, for a Global Pharma company. Established key cross-functional processes, resource balancing mechanisms, governance systems and capability enhancement initiatives to drive productivity improvement- Led the development of a global quality review structure for a leading biopharmaceutical company. Developed key metrics for the quality function and built a tiered review system, involving reviews at the site, corporate and leadership levels- Led a regulated market facility inspection readiness effort at a Biologics API plant of a Global generics manufacturer. Engaged the site through an intensive preparation schedule by managing key activities such as walkthroughs, coaching, storyboard creation, document traceability, mock audits, closure of observations, trainings, review of events, etc. Operations Due Diligence- Conducted operations due diligences for leading Pharma companies. Analysed and benchmarked manufacturing capabilities, conducted cost position analysis and analysed supply stability and risk SCM and EPM related Business Proposals- Led multiple business proposals in relation to supply chain digitization and enterprise performance management