Responsible for managing Whole ModernaTx Inc., Doc Control activities during Weekends.

• Directed a specialized project to develop comprehensive Standard Operating Procedures (SOPs) for the formatting, analysis, and validation of SOPs, FRMs, MBRs, WIs, Policies, and other critical documents, establishing a foundational framework for the implementation of new Veeva Vault in 2024.
• Implemented advanced document management systems that enhanced accessibility and reduced processing time, optimizing workflow efficiency by 20%.
• Partnered with management and supervisory personnel form Operations, Quality Control, and Quality Assurance to proactively resolve challenges affecting product quality, conducting meticulous investigations and diligent follow-ups to address non-conformance issues effectively.
• Spearheaded validation activities and adeptly managed the Change Control process for computer systems, ensuring compliance with regulatory standards while expertly formatting validation protocols, deviations, and documentation to align with client specific templates and standards.
• Responsible for identifying deviations in the processes that ensure all activities are cGMP compliant,identifying corrective actions, assisting with RCA, establishing path forward activities and appropriate documentation is complete.
• Evaluated QA performance by leveraging Lean Six Sigma methodologies to extract and analyze data, pinpointing root causes of performance gaps and QA issues; conducted comprehensive final QA reviews, delivering decisive dispositions for investigations, deviations, and corrective action plans (CAPs).
• Executed comprehensive periodic reviews of seventeen Quality GxP systems, ensuring robust maintenance and compliance within a validated state of control.
• Orchestrated the development and management of comprehensive change control documentation, including Change Request Forms, Change Control Implementation Plans, and Change Control Summary Reports, ensuring precise tracking and flawless execution.
• Established and verified rigorous quality standards and testing procedures, adapting quality assurance programs to meet specific user requirements and data inputs.
• Exemplified exceptional project and process management skills by independently leading multiple complex initiatives and cross-functional process, consistently achieving established deadlines.
• Conducted thorough audits of change management systems to verify adherence to SOPs and maintain process integrity.
• Ensured strict compliance with 21 CFR Part 11 and cGXP regulations, safeguarding process reliability and regulatory alignment.