Divya M Email & Phone Number

Austin, Tx, Us

Cambridge, Massachusetts, United States

• At Biogen, I led the business analysis for a Manufacturing Execution System (MES) upgrade aimed at enhancing production efficiency and regulatory compliance. I worked closely with cross-functional teams to define system requirements and map production workflows in alignment with GxP standards. I conducted gap analysis, identified areas for improvement, and facilitated the transition to electronic batch records (EBR). I oversaw the validation of the system through risk assessments and change control processes, ensuring compliance with FDA regulations. This project optimized real-time data capture, improved traceability, and reduced production cycle times, contributing to overall manufacturing efficiency.• Developed and implemented SOX and GxP compliance frameworks, ensuring adherence to regulatory standards.• Conducted thorough business requirements analysis to understand pricing and revenue management needs.• Collaborated with cross-functional teams to design, document, and implement controls and procedures for SOX and GxP compliance.• Created and executed UAT scripts for validation and system acceptance, ensuring alignment with 21 CFR Part 11 requirements.• Created detailed compliance reports and dashboards, leveraging data analysis tools to monitor compliance status and trends.• Collaborated with cross-functional teams to ensure the system complied with GxP, ICH, and FDA requirements.

Thousand Oaks, California, United States

Spearheaded the implementation of Veeva Rim Suite, a comprehensive regulatory information management solution, to streamline regulatory processes and ensure compliance with industry standards.Conducted stakeholder interviews and workshops to gather business requirements for Veeva Vault implementation.Identified and implemented process improvements to enhance efficiency and effectiveness of business operations through Salesforce and Model N solutions.Conducted in-depth analysis of business requirements and regulatory needs to design and configure the Veeva Rim Suite modules accordingly.Defined clear and comprehensive acceptance criteria for each user story, outlining the specific conditions that must be met for the story to be considered successfully implemented and accepted by end-users.Acted as a liaison between clients and SaaS vendors, facilitating communication and advocating for client needs to ensure timely resolution of issues and alignment with service level agreements.Collaborated with cross-functional teams to configure and customize Veeva RIM Registration modules, aligning with SAP data structures and business processes, ensuring a synchronized and streamlined workflow.Oversaw the migration of legacy regulatory data from existing systems to Veeva RIM, ensuring data integrity, accuracy, and compliance with regulatory standards.Ensured compliance with regulatory requirements and internal governance policies in all Salesforce and Model N activities.Leveraged Veeva Rim Suite's configuration capabilities to tailor the system to specific business requirements, including configuring metadata, document types, and submission templates.Communicated SQL-related insights and findings effectively with stakeholders, bridging the gap between technical and non-technical audiences, and ensuring alignment with project objectives.

Boston, Massachusetts, United States

Coordinated with external vendors and consultants to leverage their expertise in Salesforce and Model N implementations.Identified and implemented process improvements to enhance efficiency and effectiveness of business operations through Salesforce and Model N solutions.Developed and maintained dashboards and reports in Salesforce and Model N to provide actionable insights for business decision-making.Spearheaded the evaluation and selection of regulatory systems, meticulously aligning features and capabilities with organizational needs and regulatory requirements.Monitored and assessed the effectiveness of GxP controls and processes through regular audits and inspections, implementing corrective actions as needed to maintain compliance.Ensured compliance with regulatory requirements and internal governance policies in all Salesforce and Model N activities.Provided training and support to stakeholders on GxP principles, procedures, and system usage, promoting a culture of compliance and accountability.Managed validation activities for GxP systems and processes, coordinating validation protocols, execution, and documentation to meet regulatory expectations.Managed integrations between Salesforce, Model N, and other third-party applications, ensuring seamless data flow and system interoperability.Implemented robust documentation practices, including SOPs (Standard Operating Procedures) and work instructions, to ensure clear guidelines for GxP processes and activities.

Westchester County, New York, United States

Oversaw project timelines, deliverables, and resources to ensure successful implementation and maintenance of Veeva Vault applications.Provided training sessions and ongoing support to end-users to ensure effective utilization of Veeva Vault applications.Led the requirements gathering and analysis for Veeva Regulatory projects, ensuring alignment with business needs.Lead efforts to plan and execute the seamless integration of Medicare with Medicaid, ensuring cohesive functionality and data exchange between the two healthcare programs while minimizing disruptions to ongoing operations.Created comprehensive documentation including user manuals, system configuration guides, and process workflows to support regulatory operations.Configured and customized Veeva Vault applications to optimize regulatory workflows and processes.Foster collaborative relationships with healthcare professionals, administrators, and government agencies involved in Medicare and Medicaid, facilitating effective communication and ensuring alignment with program objectives.Identified opportunities for process enhancements and implemented best practices to optimize regulatory workflows.Collaborated with stakeholders to understand regulatory requirements and translate them into functional specifications for Veeva Vault implementations.Specialize in designing and maintaining SQL database schemas, ensuring logical data organization, normalization, and adherence to best practices for scalability and efficiency.Addressed and resolved any issues related to Veeva Vault configurations and regulatory processes promptly.