Quality Assurance Continuous Improvement
Resume:
Ankit Patel
*******************@*****.***
Summary
Dynamic Clinical Quality Assurance Leader with over 10 years of experience in the biotech industry. Expert in designing and implementing GCP/GCLP-compliant quality systems, managing rigorous regulatory inspections, and leading cross-functional teams to drive continuous improvement. Proven track record in audit excellence, risk-based quality management, and regulatory oversight to ensure patient safety and data integrity. Adept at reducing compliance risks and optimizing quality processes through strategic initiatives.
Core Competencies
GCP/GCLP Compliance & Auditing
FDA, EMA, ICH Regulatory Standards
Quality Management Systems (QMS)
CAPA, Change Management & Deviation Handling
Risk Analysis & Root Cause Analysis
Inspection Readiness & Health Authority Liaison
Cross-Functional Collaboration & Leadership
Clinical Documentation & IND/NDA Review
Professional Experience
Manager, Quality System
Adaptive Biotechnology, South San Francisco, CA
November 2022 – Present
Established and maintained GCP QA programs, policies, and procedures to ensure clinical programs met regulatory requirements.
Acted as the primary GCP QA subject matter expert and point of contact for all GCP/GCLP-related matters.
Developed and executed study-specific audit plans, conducting audits and managing external quality auditors.
Led Quality Review Board meetings, prepared KPIs, and tracked key performance metrics.
Conducted root cause analysis for recurring compliance issues and implemented corrective and preventive actions (CAPA).
Spearheaded inspection readiness strategies, reducing compliance findings by 30% during regulatory inspections.
Provided quality oversight across internal operations and external third-party contract manufacturers (CMOs), suppliers, and service providers.
Designed and implemented quality and compliance strategies aligned with global regulatory expectations.
Manager, Clinical Services Quality
Vitalant, San Francisco, CA
February 2021 – October 2022
Developed and implemented a comprehensive GCLP quality program from the ground up, ensuring regulatory compliance and operational excellence.
Managed external regulatory inspections, coordinating responses and ensuring swift implementation of corrective actions.
Led cross-functional teams in reviewing and evaluating nonconforming products and processes, ensuring customer impact mitigation.
Supported Clinical Trial Studies by conducting data and process analyses, identifying deviations, and implementing process improvements.
Spearheaded process optimization efforts, ensuring alignment with quality and regulatory standards.
Enhanced deviation tracking and trending efforts, driving continuous improvement initiatives.
Validation Engineer
Fluidigm Corporation, South San Francisco, CA
July 2018 – May 2020
Managed PM/Calibration programs for manufacturing equipment, ensuring compliance with ISO13485 and 21 CFR Part 820.
Led equipment acceptance and validation programs, preparing and executing IQ/OQ/PQ/PPQ validation protocols.
Acted as the key liaison for equipment validation during audits.
Collaborated with external vendors to maintain compliance with equipment master plans.
Used SolidWorks to design parts and fixtures for process improvements.
Additional Experience:
Sr. R&D Engineer (Contractor) – Lucira Health (May 2020 – Sept 2020)
System Test Engineer II (Contractor) – Beckman Coulter (Sept 2017 – Feb 2018)
Research Associate II, R&D (Contractor) – Bio-Rad Laboratories (March 2017 – July 2017)
Scientist II, R&D (Contractor) – Siemens (Oct 2015 – Sept 2016)
Education
Bachelor of Science in Biology
San Jose State University, San Jose, CA
Major: Molecular Biology
Minor: Chemistry
Certifications & Training
BSI Lead Auditor certified
References available upon request.
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