Sarath Ramakrishnan

I have over 10 years of experience implementing IT-based solutions for leading global Life Sciences organizations in the Supply Chain and Technical Operations areas. I have successfully led engagements involving IT strategy and enterprise architecture definition, gap assessments, systems implementation, GxP relevant computer systems validation and program management. I am adept at developing and sustaining long term relationships with clients and managing cross-functional, geographically distributed teams involving business, technical and executive-level teams.

My recent experiences have been working with life sciences organizations in implementing solutions to comply with global serialization and product traceability regulations and digital enablement of technical operations & associated business processes (manufacturing, packaging, distribution, artwork/labeling, etc.).

Engagement experience

• Product Serialization & Tracking Program: I led the solution implementation for a global Scope of work has included business requirements analysis, system gap assessments, solution implementation across Packaging, Distribution, QA, Supply Chain, Regulatory Affairs and IT. Throughout this project, I supported leadership and key stakeholders across the organization as they navigated processes, IT transformational challenges and managed a multidisciplinary KPMG cohort to implement the solution well ahead of various regulatory deadlines.
• Distribution Center (DC) Automation project: I led solution implementation for a global pharmaceuticals manufacturer to streamline and automate DC operational processes. These process automation and technology tools improved DC operational efficiencies and reduce total cost of ownership. Solution provided tighter integration with client’s Order Management & Warehouse systems and DC equipments, enhanced user experience & operator efficiency and provided better reporting & analytics capabilities for management. I led the requirements gathering, gap assessment and process design workshops, solution implementation, and project management activities to implement the solution within budget and timelines.
• Shop Floor Integration project: For a major pharmaceuticals company, I deployed a solution at the client’s manufacturing and packaging shop floor to integrate various equipments with electronic process instruction sheets in order to automate data capture in the master batch records. This improved operational efficiencies and data integrity which ensured product quality and regulatory compliance. I was responsible for the overall project management and managed the validation testing activities (based on GxP regulations and Title 21 CFR Part 11 of the FDA guidelines).
• Aggregate Spend Solution: I implemented a solution for the client to comply with the US Physician Payment Sunshine Act regulations for tracking, monitoring and auditing marketing & promotional expenses incurred by employees and suppliers. This solution involved data sourcing and process choreography from multiple ERP systems, mobile technologies, integration and reporting applications using a Business Process Management (BPM) tool. I led the program and project management and solution implementation activities for successful deployment of the solution.