Remya Ramachandran
chatham,New Jersey
Summary
Quality Assurance professional with seven years of experience in clinical quality, specializing in GCP audits, inspection readiness, and vendor oversight. Proven track record in audit preparation and execution, with minimal findings, quality risk management, process harmonization, and change management during mergers. Skilled in quality systems, document control, and driving compliance and operational excellence.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Lead, Operation QA and Compliance
Clario
Philadelphia, Pennsylvania
05.2025 - 11.2025
- Led end-to-end audit preparation activities, including planning, documentation readiness, and team coaching, resulting in minimal to no audit findings across multiple clinical program audits.
- Executed internal, vendor, and process audits in alignment with GCP, ICH E6(R2), and organizational QMS requirements; prepared comprehensive audit reports and follow-up CAPA oversight.
- Conducted critical forecasts and high-risk audits to ensure regulatory and study compliance, contributing to sustained inspection readiness and reduced compliance risk.
- Facilitated external audits and inspections by coordinating cross-functional teams, managing client and vendor communication, and ensuring the timely delivery of required evidence and documentation.
- Supported post-acquisition integration and change management, harmonizing processes, SOPs, and quality standards across newly merged organizations.
- Collaborated with cross-functional leadership to drive process improvement, streamline workflows, and strengthen governance frameworks across clinical operations and quality teams.
- Mentored study teams and vendor staff on audit expectations, documentation standards, and GCP principles, increasing audit readiness and quality culture.
- Utilized structured root cause analysis and risk-based strategies to evaluate issues and ensure effective CAPA development, implementation, and verification.
Lead, Operations QA and Compliance
WCG
Princeton, New Jersey
10.2021 - 04.2025
- Led audit planning, preparation, and execution activities for internal, external, and vendor audits, ensuring documentation readiness and cross-functional coordination.
- Hosted and supported 200+ external client audits and multiple regulatory inspections, consistently resulting in minimal to no critical findings.
- Supported ongoing inspection readiness efforts by preparing study teams, verifying evidence packages, and coordinating responses to inspection requests.
- Conducted risk-based audit selection and prioritization, contributing to proactive compliance oversight and continuous improvement of clinical quality practices.
- Played a key role in process integration and harmonization during multiple organizational acquisitions, ensuring alignment of SOPs, workflows, and governance models.
- Supported change management activities during mergers and transitions, including communication planning, training, and phased rollout of revised processes.
- Participated in controlled document development and maintenance, including SOPs, policies, work instructions, and quality frameworks.
- Monitored CAPA development and closure to ensure timely resolution, effective verification, and sustained compliance improvements.
- Led quarterly Quality Risk Meetings with senior leadership, reviewing the organizational risk register, monitoring emerging quality risks, and driving accountability for mitigation plans.
- Performed extensive data extraction and quality metrics analysis for monthly and annual Quality Management Reviews (QMR), ensuring accurate reporting of trends, signals, audit outcomes, and CAPA effectiveness.
- Performed vendor qualification and ongoing vendor oversight, including conducting vendor audits, monitoring performance KPIs, evaluating compliance risk, and ensuring timely CAPA implementation to maintain service quality and regulatory alignment.
Senior Associate, Operations QA and Compliance
WCG
Princeton, New Jersey
01.2021 - 09.2021
- Managed end-to-end audit preparation and execution for external client audits, ensuring readiness and consistently achieving minimal findings.
- Collaborated with teams to create and implement internal standards, ensuring regulatory adherence.
- Oversaw integration of businesses as a subject matter expert in process harmonization.
- Investigated Quality Events/CAPAs and documented findings comprehensively.
- Conducted vendor qualification audits to verify compliance with organizational regulations and processes.
- Developed, maintained, and enforced Quality Management System to enhance operational efficiency.
- Established quality goals and objectives, driving continuous process improvements.
- Enforced department standards across all functions to ensure compliance and consistency.
- Coached staff on quality standards, promoting best practices organization-wide.
QA Associate
Medavante-ProPhase
Hamilton, NJ
02.2019 - 01.2021
- Executed internal GCP, QA, and Operations audits to verify adherence to standards.
- Hosted GCP, QA, and Operations audits to enhance operational visibility.
- Assisted with regulatory inspections to support compliance efforts.
- Consulted personnel on audit findings, and identified process improvement opportunities.
- Defined issues, gathered data, established facts, and analyzed causation versus correlation.
- Served as System Administrator for the Training Management System and Quality Event Management Systems, ensuring accurate data, streamlined reporting, and efficient support of quality processes.
Research Assistant
Cancer 101
New York, New York
05.2018 - 01.2019
- Developed groundwork for patient education on ethical issues such as bias and transparency.
- Executed extensive research on guiding principles, creating dedicated documents for each.
- Summarized and organized a collection of pertinent literature and research articles.
- Engaged in weekly discussions with CEO to provide updates on project status and deliverables.
Member, Ethics Committee (Practicum)
Bellevue Hospital
New York, New York
03.2018 - 09.2018
- Engaged with the Hospital Ethics Committee to assist patients and families with ethical concerns.
- Scrutinized prior medical decisions for moral, legal, and ethical justification.
- Counseled on end-of-life care choices, and the implications of treatment withdrawals.
- Supported resolution of ethical challenges faced by healthcare professionals.
Education
Master of Arts - Bioethics
NYU College of Global Public Health
New York, NY08-2018
Master of Science - Biotechnology
Bharathiar University
India06-2007
Skills
Core GCP & Clinical Quality skills
- Good Clinical Practice Compliance
- Clinical Trial Quality Oversight
- Internal and External Auditing
- Vendor Qualification and Oversight
- CAPA Management
- Regulatory inspection readiness (FDA, EMA, MHRA, PMDA)
Process and Operational Excellence
- Process Harmonization Across Business Units
- Integration and Quality Alignment During Mergers and Acquisitions
- Change Management and Organizational Transitional Support
- Continuous Process Improvements
- Quality Metrics Development and Monitoring
Certification
- Lean Six Sigma Yellow Belt WCG Clinical 10-Dec-2019
- Good Clinical Practice/ICH E6 R2 WCG MAGI 21-May-2023
- ISO 9001:2015 Requirements(TPECS) BSI 06-Sep-2022
- Auditing Module (TPECS) BSI 21-Sep-2022
Timeline
Lead, Operation QA and Compliance
Clario
05.2025 - 11.2025
Lead, Operations QA and Compliance
WCG
10.2021 - 04.2025
Senior Associate, Operations QA and Compliance
WCG
01.2021 - 09.2021
QA Associate
Medavante-ProPhase
02.2019 - 01.2021
Research Assistant
Cancer 101
05.2018 - 01.2019
Member, Ethics Committee (Practicum)
Bellevue Hospital
03.2018 - 09.2018
Master of Arts - Bioethics
NYU College of Global Public Health
Master of Science - Biotechnology
Bharathiar University