Summary
Overview
Work History
Education
Skills
Accomplishments
Certification
Community Service
Affiliations
KEY QUALIFICATIONS
Excellent networking and public services
Languages
Interests
Timeline
Generic
Moe Imran

Moe Imran

Columbia,USA

Summary

Experienced and highly dedicated professional with over 25 years in regulated environments, including GLP and GCP. Proven expertise as a Lead Auditor for clinical and non-clinical programs, managing audit plans, quality inspections, and site compliance. Effective mentor and coach with deep insight into career transitions, relationship building, and stakeholder engagement. Recognized for strong communication, analytical, and organizational skills. Dynamic mentor and coach with deep insight into career transitions and professional development. Consistently successful in cultivating strong relationships across diverse individuals and organizations. Known for exceptional communication, analytical, and organizational strengths.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Quality Assurance Manager

Technical Resources International, LLC
- 05.2025

Quality Assurance Manager (Lead Auditor)

FDA QRC
04.2014 - 10.2024
  • Oversaw Quality Management System for conducting audits at the site in person and remotely on behalf of sponsors (Pharmaceuticals, Biopharmaceuticals, academics and Federal agencies).
  • Reviewed and audited internal quality internals and provided executive level support to the management of the Quality assurance team.
  • Liaised with the Standard Operating Procedure (SOP) administrator for conducting periodic review of SOPs according to the company policy and procedures. and oversee annual internal audits for the facility and process audits.
  • Maintained continuity within the Project managers for reaching out the clients for scheduling audits. Complete deliverables by meeting or exceeding expectations as outlined in the Collaboration Plan, Audit Plan, and Audit agenda. Review document management process, Data Safety, filing, and archiving. Review lab manuals as relevant to the study protocol. All study manuals IP shipment records filed at the site level and their method of filing such as via eTMF, SharePoint, EMR, e-diaries etc. Reviewed maintenance records for facilities and Equipment. Investigational Medical Product (IMP) shipment and storage (accountability records), Lab storage/Temperature Review Logs. Review CAPA and Audit Trail Log. Responds to queries and pending items Supervised and coached staff auditors, including study coordinator, events coordinator, and residents and fellows at the investigator site for conducting audits for Phases 1-3 of clinical trials.

Associate Director of Quality Assurance

Zigzag Associates LTD
11.2022 - 11.2023
  • Performed audits at various sites on behalf of sponsors for conducting audits for promoting compliance with Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams with compliance guidance support related to GCP global regulations and guidelines. In addition to GCP FDA 21 CFR Part 58 for Good Laboratory Practice (GLP), World Health Organization (WHO) Guidelines for Good Clinical Laboratory Practices (GcLP), OECD Principles of GLP, FDA Guidance for Industry Bioanalytical Method Validation, and 21 CFR Part 11 Electronic data system. Based on the audit agenda review assay validation, sample analysis, facility audits, process audits, vendor audits, and periodic SOP reviews. Reviews regulatory inspections for IND/BLA/ PMDA and other types of inspections. Provide a variety of Quality Assurance (QA) services to external clients and to conduct contracted activities following contractual requirements, regulations, guidelines, and Standard Operating Procedures (SOPs).

Senior QA Specialist/ Associate Director (Lead Auditor)

Amador Bioscience
08.2022 - 11.2022
  • Conducted audits for promoting compliance with US Code of Federal Regulations (21 CFR Part Electronic Records; Electronic Signatures, 21 CFR Part 820 –
  • Good Automated Manufacturing Practice (GAMP) 5 Standard, and Catalyst Pharmaceutical Inc. vendor agreements and process requirements.

Associate Director, Clinical Quality Assurance, Contractor

Novavax Pharmaceuticals
06.2022 - 08.2022
  • Provided guidance to other auditors for conducting audits for assay validation, sample analysis, facility audits, process audits, vendor audits, and periodic SOP reviews and regulatory inspections for IND/BLA/ PMDA and other types of inspections. Provide a variety of Quality Assurance (QA) services to external clients and to conduct contracted activities in accordance with contractual requirements, regulations, guidelines, and Standard Operating Procedures (SOPs).
  • Implemented and maintained a comprehensive risk-based GCP compliance program, ensuring adherence to Sponsor SOPs and utilized ISA's systems for electronic data capture and management. Independently managed, conducted, and reported investigator site, vendor, and internal process/function audits on-site and remotely.

Senior Quality Assurance Auditor, Fulltime employee

Smithers Pharmaceutical Development Services, LLC
12.2015 - 06.2022
  • Conducted all Bioanalytical validation audits for PK, ADA, Nab and Biomarkers projects. Provided technical assistance in validation activities of software for compliance to 21 CFR Part 11.
  • Assists in review of IQ, OQ and PQ validation test plans and summary reports for equipment/software.
  • Performed phase inspections, protocol, data, final report audits and post audits of final reports of Bioanalytical tests for compliance with appropriate regulations, SOPs, and sponsors-approved protocol. Audit study reports as samples were analyzed for the quantification by Electrochemiluminescence Method. The data were captured by using Meso Scale Discovery (MSD) Sector Imager 2400 Discovery Workbench software and data regression was done by Watson LIMS

Quality Assurance Consultant, Contractor

Moderna
04.2019 - 06.2019
  • Funded by BARDA.

Quality Assurance Consultant, Contractor

University of Maryland, Physician Associates
09.2015 - 12.2015

Senior Quality Assurance Specialist, Contractor

School of Medicine, University of Maryland
11.2005 - 05.2015
  • Funded by NIAID, 10 years project.

Education

Master of Health Care Administration -

California State University
Long Beach, CA
08.1999

Clinical Laboratory Scientist Internship - Medical Technologist

Columbia Health Care Corporation
Anaheim, CA

HOSPITAL ADMINISTRATION INTERN - undefined

West Anaheim Medical Center
Anaheim, CA

Bachelor of Science - Chemistry

University of Oklahoma
Norman, OK
12.1986

Skills

  • Google Workspace: Docs, Sheets, Slides, Forms, Calendar
  • Microsoft Office Suite: Excel, Word, Outlook, PowerPoint
  • Clinical and Lab Systems: Nave Medidata, Epic (Clinical Trials), Empower (HPLC/UPLC), Watson LIMS
  • Collaboration Tools: SharePoint, Zoom, MS Teams, HubSpot
  • Cloud Platforms: Azure, Amazon Web Services (AWS)
  • Disaster Recovery Tools and Utilities
  • Adobe Suite
  • Internal audits
  • Continuous improvement
  • Quality assurance management
  • Audit coordination
  • Quality systems
  • Attention to detail
  • Employee training
  • Performance metrics
  • Audit reporting
  • Process analysis
  • Risk analysis and mitigation
  • Work Planning and Prioritization
  • Documentation review
  • Employee supervision
  • Quality assurance background
  • Systems analysis
  • Progress reporting
  • Complaint investigation
  • Trend analysis
  • Presentations
  • Goals setting
  • Operations management
  • Deficiency detection
  • Process development
  • Best practices
  • Validation techniques
  • System development
  • Personnel training
  • Quality standards determination
  • Pre-implementation audits
  • Team building
  • QA reporting
  • GAMP systems expert
  • QA documentation
  • Quality assurance guidance
  • Organizational performance evaluation
  • Quality assurance experience
  • Process documentation
  • Performance monitoring
  • Critical thinking
  • Effective multitasking
  • Team collaboration
  • Interpersonal communication
  • Statistical analysis
  • Defect identification
  • QMS

Accomplishments

  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Achieved [Result] by introducing [Software] for [Type] tasks.
  • Resolved product issue through consumer testing.
  • Documented and resolved [Issue] which led to [Results].
  • Collaborated with team of [Number] in the development of [Project name].
  • Achieved [Result] by completing [Task] with accuracy and efficiency.
  • Achieved [Result] through effectively helping with [Task].

Certification

  • Renewable every two years by maintaining continuing education of 12 contract hours
  • Laboratory Field Services & College of Pathology (CAP/ASCP), California Department of Health, Mar 1994- Mar 2027. Clinical Laboratory Scientist (CLS), California #MTA36222
  • Medical Laboratory Scientist, MLS(ASCP), ID# 25346057, Exp, Feb 2026

Community Service

River Hill Village of Howard County of Maryland, River Hill Community Association, Board Member (Re-Elected), 2023, 2027

Affiliations

  • Member of Society of Quality Assurance (SQA)
  • Member of Computer Validation Initiative Committee (CVIC) of SQA

KEY QUALIFICATIONS

  • Performing audits in regulated environments
  • Delivering Presentation and preparing detailed reports
  • Designing and executing comprehensive audit plans
  • Overseeing and enhancing quality Management systems
  • Review and audit standard operating procedures.
  • Project and time management expertise
  • Strong communication and interpersonal skills
  • And Management
  • Leading onboarding and training initiatives
  • Coordinating and hosting regulatory inspections
  • Overseeing periodic operations and logistics as an independent Quality Assurance Lead Auditor/Manager

Excellent networking and public services

Proven experience hosting regulatory inspections and engaging effectively with clients during clinical trial site audits. Skilled Lead Auditor with a strong background in building and guiding audit teams to ensure thorough and compliant evaluations. Adept at leveraging professional networking and relationship-building skills to maintain client satisfaction and foster long-term partnerships.  Demonstrated ability to identify deficiencies during audits and develop effective mitigation strategies to ensure regulatory compliance and continuous quality improvement.   Skilled in prioritizing client needs and consistently delivering tailored solutions within established timelines.

Languages

French
Professional Working
Hindi
Professional Working
Bengali
Native or Bilingual
English
Full Professional

Interests

  • Volunteer Travel
  • Historical Exploration
  • Sharing travel tips, recommendations, and insights with fellow enthusiasts
  • Documenting and sharing travel experiences
  • Exploring famous landmarks, historical sites, and cultural attractions in a new destination
  • Adventure Travel
  • Train Travel

Timeline

Associate Director of Quality Assurance

Zigzag Associates LTD
11.2022 - 11.2023

Senior QA Specialist/ Associate Director (Lead Auditor)

Amador Bioscience
08.2022 - 11.2022

Associate Director, Clinical Quality Assurance, Contractor

Novavax Pharmaceuticals
06.2022 - 08.2022

Quality Assurance Consultant, Contractor

Moderna
04.2019 - 06.2019

Senior Quality Assurance Auditor, Fulltime employee

Smithers Pharmaceutical Development Services, LLC
12.2015 - 06.2022

Quality Assurance Consultant, Contractor

University of Maryland, Physician Associates
09.2015 - 12.2015

Quality Assurance Manager (Lead Auditor)

FDA QRC
04.2014 - 10.2024

Senior Quality Assurance Specialist, Contractor

School of Medicine, University of Maryland
11.2005 - 05.2015

Quality Assurance Manager

Technical Resources International, LLC
- 05.2025

Clinical Laboratory Scientist Internship - Medical Technologist

Columbia Health Care Corporation

HOSPITAL ADMINISTRATION INTERN - undefined

West Anaheim Medical Center

Bachelor of Science - Chemistry

University of Oklahoma

Master of Health Care Administration -

California State University