Bishrut Bikram Thapa

• Managed complex Quality Issue investigations through cross-functional collaboration with Regulatory Affairs, Clinical Safety, and Pharmacovigilance teams using VEEVA for timely resolution.
  •Oversaw business partner audits and Health Authority inspections, managing pre-inspection activities and post-inspection responses including CAPA and stakeholder communication.
  •Facilitated Communities of Practice meetings, developing global agendas and promoting knowledge-sharing initiatives for improved team alignment.
  •Mentored APPE rotation students and coached junior staff on quality systems and strategic career development.
  •Served as Subject Matter Expert in Regulatory Affairs, Pharmacovigilance, and Clinical Safety to enhance compliance awareness and capability building.
  •Authored and reviewed SOPs related to GVP and GCP, ensuring adherence to regulations and company policies while delivering targeted training materials.
  •Applied LEAN methodologies to streamline processes, reduce waste, and improve cycle-time for Quality Issues and deviations.
  •Maintained documentation for Organizational Management activities, ensuring accuracy in job descriptions and CVs supported by KPI evaluations.

•Provided strategic leadership for quality activities in Sterile Supply and Validation COE, driving alignment with regulatory expectations and business objectives.
•Led and mentored a team of quality professionals overseeing deviation approvals, CAPAs, change controls, risk assessments, audit responses, SOP development, and quality documentation.
•Reduced Quality Issue and Deviation cycle times by 20% through targeted process improvements and cross-functional collaboration.
•Improved overall Quality approval times by 15%, accelerating decision-making and operational efficiency across all quality functions.
•Spearheaded inspection and audit readiness efforts, resulting in zero audit or inspection findings by implementing robust Quality walkthrough programs and cross-departmental coaching on inspection conduct.
•Enhanced the Batch Record Review program by eliminating all backlog, ensuring timely and compliant batch release activities.
•Developed and refined SOPs in collaboration with cross-functional teams to continuously improve processes and respond proactively to evolving regulatory requirements.
•Strengthened quality systems management, including document control, deviations, CAPAs, and change control, maintaining high GMP compliance standards.
•Established enhanced KPI monitoring through Tier metrics development and regular performance review meetings with Operations and Technical Operations leadership, improving transparency and accountability.
•Managed department leadership during inspections and audits, directly engaging with inspectors and auditors to facilitate smooth and compliant assessments.
•Advocated for and cultivated a culture of continuous improvement, identifying process optimization opportunities and driving quality enhancements throughout the organization.
•Contributed to the development and execution of the organization's quality strategy, ensuring alignment with industry trends and long-term business goals.

•Oversaw global audits and Health Authority inspections for Pharmacovigilance and Clinical Safety groups, providing strategic leadership for preparation, SME training, hosting, and post-audit follow-up.
•Delivered advanced SME training on audit and inspection management, leveraging tools such as ACE and Box to enhance readiness and response capabilities.
•Served as Process Owner for Deviation/Quality Issues and Notification to Management (NTM) within VEEVA, driving a 25% reduction in deviation cycle time through process optimization and cross-functional collaboration.
•Ensured the Pharmacovigilance Quality Management System (PV QMS) was sustainable, executed effectively, and continuously improved to maintain compliance, and operational excellence.
•Implemented and sustained a robust CAPA system, including KPI monitoring and trend analysis, coaching SMEs in the development of effective, SMART corrective actions.
•Managed a comprehensive inspection readiness program globally for pharmacovigilance and clinical safety teams, incorporating quality risk management, ongoing SME development, and continuous improvement initiatives.
•Led the update and alignment of quality policies, SOPs, and documentation to meet evolving regulatory requirements and industry best practices.
•Directed and mentored a high-performing matrix team, fostering professional growth, and enhancing team effectiveness across multiple regions and functions.
•Championed collaboration with cross-functional stakeholders to resolve audit findings promptly and prevent recurrence, strengthening overall quality governance.

•Managed global audits and Health Authority inspections for pharmacovigilance, leading preparation activities, SME training, hosting, and post-audit follow-up to ensure compliance and readiness.
•Developed and delivered comprehensive audit and inspection management training, including advanced mock interview techniques, utilizing ACE and Box tools.
•Led the Deviation/Quality Issue process as a key collaborator with Quality Governance, refining procedures through Quality Metrics, and oversight of the CAPA system with trend analysis reporting.
•Coached SMEs in creating SMART CAPAs, and coordinated cross-functional efforts to resolve audit findings and prevent recurrence effectively.
•Played a pivotal role in implementing eQMS changes (VEEVA) globally and regionally, and developed a Notification to Management program for GVP in partnership with GxP teams.
•Supported organizational integrations by successfully negotiating and deploying the Deviation and Notification to Management programs.
•Managed a team focused on maintaining inspection readiness via Quality Risk Management, SME development, and continuous improvement initiatives.
•Implemented efficient methodologies for conducting internal and external audits, including remote coordination with cross-functional teams to improve audit efficiency.
•Updated and maintained quality policies and standards to align with regulatory expectations, and leveraged industry best practices to enhance the Pharmacovigilance QMS.
•Built and nurtured strong supplier and vendor relationships, ensuring adherence to GxP standards, and fostering a culture of quality throughout the supply chain.

•Provided quality leadership through full ownership and execution of the site Quality Management System (QMS), overseeing core elements such as Deviation, OOS, Change Control, Document Management, Audit/Inspection Management, Training, Customer Complaints, CAPAs, Data Integrity, and Validation.
•Managed a team of Quality Specialists and Senior Specialists by assigning daily responsibilities, providing training and coaching, and ensuring optimal resource allocation to meet business needs.
•Maintained GMP compliance of Quality Control (QC) laboratories at all times through proactive internal audits, routine walkthroughs, and close collaboration with QC leadership.
•Led end-to-end management of regulatory and third-party audits/inspections (FDA, MHRA, ISO), including pre-audit planning, hosting, post-audit response, and CAPA implementation.
•Served as site lead for root cause analysis and deviation investigations, coaching site teams on the use of RCA tools (5 Why, Fishbone, 6M, Process Mapping), and acted as the final QA approver for all site deviations.
•Spearheaded the enhancement of the Supplier Qualification Program by leading the transition from a paper-based to an electronic system, significantly improving oversight and traceability.
•Prepared and executed internal and supplier audit schedules, ensuring full alignment with 21 CFR Parts 210, 211, 820, ISO 9001:2015, and internal SOPs.
•Updated quality policies, SOPs, and related procedures in collaboration with global and regional stakeholders to align with evolving regulatory expectations, and ensure inspection readiness.
•Championed continuous improvement initiatives across the site using DMAIC methodology, resulting in a 10% improvement in turnaround time for test results, a 20% reduction in overall deviations, and a 15% reduction in human error-related deviations.
•Acted as the Site SME for Data Integrity, leading DI assessments, supporting ALCOA+ principles, and driving enhancements to the site's data integrity program through rigorous reviews and software upgrades for laboratory systems.
•Reviewed and approved validation protocols and reports, including Method Validation, Method Transfer, Computer System Validation (CSV), and Equipment Qualification for both analytical and microbiological systems.

• Managed the batch record review team of 6 members to ensure requests from clients are performed correctly and timely.
• Ensured the analytical and microbiological labs met the company quality and regulatory requirements.
• Assisted clients in the interpretation and explanation of Compendial and standard procedures.
• Managed the department’s OOS system and provided trending reports for departmental and management review.
• Assisted site leadership with the QMS through close collaboration with QA Manager in managing and maintaining Deviation, CAPA, Customer complaint, and Supplier Qualification (Vendor Qualification) systems in accordance with relevant company SOPs.
• Provided technical expertise for impact assessment investigations pertaining to Negative Control failures, System Suitability failures, Deviations and OOS/OOT events.
• Provided training for the technical staff to advance the quality of testing services and notified of compendial updates.
• Played a lead role in department projects designed to improve the efficiency and overall quality of the work in the laboratories leveraging Lean Six Sigma, 5S, and Kaizen principles.
• Conducted internal audits to ensure compliance of both the Chemistry and the Microbiology labs.

• Reviewed and approved documentation of lab work performed comprising various analytical, biological and microbiological testing to ensure technical accuracy and regulatory compliance in accordance with the cGMP regulations.
• Proficiently leveraged Laboratory Information Management System (LIMS) to generate COA for customers.
• Reviewed and approved Systems such as, Environmental monitoring (EM) and Site Purified water, and Instrument qualification protocols, data, and final reports prior to release.
• Led laboratory OOS and Deviation investigations, authored test methods, SOPs and drafted test plans.
• Trained other microbiologists on cGMP documentation, aseptic technique, microbiological testing procedures, microbiological data analysis and other lab process of a GMP laboratory.
• Acted as the subject matter expert for Audits and Inspections pertaining to special microbiological projects, method verifications, investigations, validations, and SOP drafting.
• Initiated change controls to ensure compliance and increase efficiency in the microbiology lab through participation in lean Six Sigma and Kaizen initiatives.
• Performed internal audits of the quality systems and laboratories in accordance with ISO 9001:2008 and ISO 9001:2015.

• Worked independently in conducting a wide range of USP, EP, and JP tests in a cGMP setting.
• Proficiently conducted, Bacterial Endotoxin test, PET, Microbial Limit tests, EM, Antibiotic Assay tests, Water Analysis, TOC, Conductivity, Biological reactivity and cytotoxicity tests, and various Microbiological studies in a GMP environment.
• Led Disinfectant Efficacy testing projects from protocol generation to final report while supervising 5 microbiologists.
• Prepared wide range of microbiological media and reagents and performed Environmental Monitoring tests.
• Experienced in preparation and maintenance of a variety of bacterial and fungal stock cultures.

• Performed variety of chemical and physical analyses in the wet chemistry area of the Analytical laboratory following various standard methodologies including USP, EP and JP.
• Prepared test solutions and maintained an inventory of the test solutions, chemical reagents, reference standards, and lab supplies.
• Assisted lab personnel in safe disposal of chemical waste generated in the lab.