Lavanya Subramanian

Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.

• Responsible for oversight of Organizational QMS activities
• Experienced in Planning of Internal Audits (IA) at Organizational level
• Lead, support, and represent QA for External Audits (Sponsor/Certification Body Audits)
• Proficient in Document Management Activities, which includes authoring, review, approval of controlled documents i.e., SOP/WP/GDs/forms
• Lead Legal and Regulatory process in Organization context
• Maintain and monitor Quality Assurance KPIs and trends
• Responsible for Learning Management System
• Lead and support Non-conformance activities (Issues, CAPAs, Data Breach)
• Vendor Oversight Activities (Screening and Monitoring)
• CSV – Support and oversee validation activities from QA role
• Lead Request for Information (RFIs) queries
• Experience in Gap assessments
• Experience in ISO Certificate upgrade process

• Safety Management Plan
• Project Setup in Argus database
• Investigator Meeting Slides
• Case processing regulatory submission requirements to Regulators, Investigators, Ethics Committee/Institutional Review Boards, and Cross-reporting in Clinical Trials
• Identify gaps in process and set up new requirements as needed to organize processes efficiently with authoring of controlled documents (SOPs, WPs, and GD)
• Knowledge of other Regulatory Documents
• Literature summaries (Efficacy and Safety): Literature abstracts/article screening and summarization
• 120 Day Safety reports
• Briefing document
• QC of Aggregate documents (DSUR/PBRERs)-Involved in Client bidding project assignment for QC of Aggregate documents and was successful in Client rewarding many projects

Professional Accomplishment on LinkedIn: https://www.linkedin.com/feed/update/urn:li:activity:6484796288268328960