A part of the executive leadership plays an integral role in optimizing the R&D portfolio/pipeline strategy and supporting the commercial sales team and general management of USA and Asia sites.

Optimize effectiveness and efficiency of the Analytical function are achieved or exceeded Act as an SME (Subject Matter Expert) for all analytical activitiesLead, mentor and manage performance of Analytical staff (ARD), including training, setting goals and objectives.Review technical documentation, also review the data for integrity.Serve as a scientific and technical representative; acted as a liaison for the Division regarding technical matters and client relationship management.

Represented as Quality leader in regulatory inspections such as USFDA (USA)Provided compliance to the regulatory deficiencies, Strengthen Quality Control Systems by enriching policies and governing SOP’s.Provided technical guidance for investigation and resolution process of non-conformance including Out of Specification (OOS), Out of Trend (OOT), Analytical Incidences,Conducted due diligence for business expansion.Played active role in work simplification, process corrections and productivity enhancement.Introduction of Invitro studies acting as an SME for about 9 critical molecules which include Phosphate binding studies and Bile acid binding studies.Deliver complete end to end knowledge of new generic drugs approval and knowledge of regulatory submissions including CBE-30, PAS filings, 21 CFR Part 11 Compliance, and regulatory inspections.

Supervised and led multi-functional/multi-regional Global R&D SOP committee activities from QA standpoint.Promoted process improvement for Global SOP lifecycle management which includes the establishment of one harmonized global process within the organization. Managed all Global R&D SOP deviations, provide guidance to functions on CAPA development in a timely manner.Developed and implemented new Global R&D SOP Committee structure and management process.Established GxP training process and Training Representative network among US organization in order to develop and maintain functional training curricula.

Provided research and technical leadership within the Analytical Team on multiple projects and outsourcing to contract laboratories. Planned and organized laboratory personnel of six on projects based on priorities, expertise and timelines.