Responsible for the Quality Operations and Quality Engineering

Ø Leading a global Supplier quality team spanned across 8 manufacturing sites for all chemical and biologics suppliers of the Roche Diagnostics division.Ø Managing critical supplier relationships, enhancing supplier performance through due diligence, robust agreements, SCAR management, audits and supplier development to deliver high quality products.Ø Leading cross functional team to design a risk based, data driven supplier management system for dynamic monitoring transforming reactive supplier quality management into proactive supplier partnership.

Ø Lead and empower the matrix team through coaching, mentoring and rewarding. Ensure efficient usage of resources using proper delegation and creating growth environment for the team membersØ Achieved million dollar savings and 25% process optimization by innovating and orchestrating a novel “Fit for purpose” Modular QMS resulting in single ISO/MDSAP certification for 4 development and manufacturing sites.Ø Revolutionized global QMS, consolidating 48 systems into 1 streamlined mQMS, reducing from 2500 to <100 global processes. Led 100+ champions to achieve 85% successful implementation across sites and affiliates.Ø Instrumental in driving organizational change management and motivating the focus on simplicity and patient centricityØ Ensuring successful conformity assessment and product compliance for IVDR and MDR.

Ø Quality Lead for a satellite site for Roche and managing the quality system infrastructure to ensure ISO 13485 complianceØ Documentation manager for the validated Electronic Document management system (EDMS) Ø Learning Expert and administrator for site wide training deployment; build role based training matrices; rolled out quality system training program and manage complianceØ Implemented Supplier management, Internal Audit and CAPA program for the satellite siteØ Chair Quality Integration committee and local site management reviewØ Key member of the IVDR implementation projectØ Quality and Regulatory lead for the QMS harmonization program

Ø Led high complexity cross-functional global team in executing manufacturing process improvement project involving automation and testing of a critical medical device product.Ø Managed process improvement project in alignment with FDA compliant processes, innovations and engineering services. Ø Managed project scope, cost, processes, documentation and project implementation.Ø Worked with project team to create project quality plans using quality planning tools and techniques covering verification and validation of software and hardware systems; created and manage risk plan.Ø Collaborated in capacity planning effort.

Ø Managed end to end various global complex projects/programs through all phases and quality management initiatives spanning across multiple sites and functions. Ø Defined and maintained quality management system compliant to FDA QSR and other medical device standards.Ø Compliance coordinator for IEC 60601-1 re-certification program for neuromodulation products that enabled selling of products in European market.Ø Brought in significant cost savings as a Project Manager for windows XP upgrade project. Extensively collaborated with multiple functions across 20+ sites and leadership teams. Ø Established state of the art Roadmap for Excellence to help determine near, mid and long term goals using triad of people, process and technology. Ø Managed the remediation effort to harmonize and implement a global non-product software process. Ø Spear headed scrum implementation at the executive leadership level for running all the programs within a site. As a scrum champion and scrum master, partnered in widespread adoption of Scrum for development projects. Ø Deployed and managed the metrics program, dashboard deployment, resource management and effort tracking thus enabling data-driven decision making.Ø Coordinated, planned and managed integration, consolidation and acquisition efforts. Empowered and enabled business entities to seamlessly integrate to meet strategic business objectives with a higher ROI.Ø Ensured ownership and accountability at all levels for multiple programs. Aligned plans and resolved dependencies across all business functions. Managed global program risks.Ø Conceptualized and launched cross platform brown bag sessions and mentorship program across multiple sites for enhanced learning and better collaboration. The brown bag sessions ran for 5 consecutive years with each session bringing 200+ attendees.Ø Developed integration framework, site optimization model and supply chain rationalization criteria built on industry best practices.

Ø Managed quality management system including Metrics analysis, Causal analysis, Defects management and Repository management.Ø Team Leader of the ISO and CMMI L5 compatible process definition and implementation project.Ø Planned and organized the Internal Audits (Certified Internal Auditor for ISO 9001:2000).Ø Led the security awareness program on BS 7799 standard (Certified Lead Auditor for BS7799) and ISO 27001.Ø Developed ITIL compliant processes covering Service Delivery & Service Support discipline.Ø Architected the global process infrastructure using IRIS tool thus enabling quick and easy process adoption.Ø Prepared and delivered Quality trainings and Induction.

Ø Initiated the quality drive in the organization single handedlyØ Defined and deployed ISO 9001 and ISO/TS-16949 based QMS for the SW division of the companyØ Coordinated with the parent organization in Belgium for definition of the integrated processesØ Managed internal audits and reviews of all the projects.Ø Aligned practices to industry standards in engineering & project management - CMMI & ISO/TS-16949.Ø Planned and coordinated the training and induction program.Ø Managed the Quality Task Force.Ø Provided Quantitative Analysis support to projects and Program ManagersØ Defined the work-flow process in the MKS tool