Open To Work
Warren Dang
Alameda
Work Preference
Summary
Strategic leader in Quality Assurance with extensive experience in driving regulatory audit strategies and ensuring GxP compliance. Specializes in developing and optimizing global Quality Management Systems aligned with regulatory standards, while effectively leading cross-functional teams to enhance data integrity and compliance across biotech and pharmaceutical landscapes.
Overview
33
33
years of professional experience
Work History
Head of Quality Assurance/Quality Control– Consultant to CEO
MARIN BIOLOGIC LABORATORIES
Novato
10.2025 - Current
- Led Quality, Validation, and Data Integrity functions for all CRO projects, developed regulatory audit strategy, and ensured GxP compliance across GMP cell-based assays and GLP development research using JMP-19 for new CRO projects.
- Provided executive leadership for Quality Regulatory and Quality Agreement functions, reported to CEO, and shaped regulatory audit strategy and enterprise-wide GxP compliance across GMP cell-based assays and GLP development research.
- Led quality assurance initiatives to enhance product integrity and compliance.
- Developed and implemented quality control procedures for laboratory processes.
- Collaborated with research teams to ensure adherence to regulatory standards.
Owner/Principal
WDANG COMPLIANCES SERVICES
09.2015 - Current
- GLG consultant for QMS system selections across GxP and ISO environments (2025 to current).
- Consulted on QA, CSV, eQMS, and data integrity for global biotech and pharmaceutical clients, enhancing compliance and operational excellence.
- Advised on Generative Artificial Intelligence (GenAI) in Data Analytics for NoahMind AI Database LLC, supporting global cosmetic and beauty compliance initiatives.
Quality Assurance Compliance Manager, System Administrator Contractor
EXELIXIS THERAPEUTICS
Alameda
10.2024 - 05.2025
- Ensured compliance with GxP and Annex 11; authored validation scripts and supporting documentation.
- Conducted quarterly validation process reviews and implemented Veeva updates to maintain compliance and improve system integrity.
- Administered Veeva eQMS enhancements and coordinated CSV validation with IT and QA teams to ensure alignment with compliance standards.
Quality Assurance-Data Integrity Senior Director Consultant
TRAVERE THERAPEUTICS
San Diego
11.2022 - 11.2024
- Directed global Data Integrity (DI) and CMC QA compliance across CMOs/CROs for small molecule and combination products.
- Established Data Integrity Program and SOPs to ensure compliance with ALCOA++ principles and regulatory expectations.
- Implemented CMO Scorecards with KPI metrics to enhance supplier evaluation and improve audit outcomes.
- Authored and reviewed MSA and Quality Agreements for 15 external partners to align quality standards and contractual obligations.
Senior Security Advisor Consultant to the CEO
YULON Capital LLC
Beverly Hills
09.2018 - 03.2023
- Enhanced cloud-based data security and environment surveillance through personnel security risk services and supplier audits, strengthening overall security posture.
- Conducted security audits and improved protocols to reduce vulnerabilities in cloud infrastructure, mitigating potential risks.
- Assessed security risks and vulnerabilities across all company operations.
- Developed and implemented security policies and procedures for staff compliance.
- Conducted regular training sessions on security protocols for employees.
Associate Director of Managed Services Contractor
GILEAD SCIENCES
Foster City
09.2015 - 12.2018
- Led PPD Managed Services partnership, overseeing 22-person team across 3 global sites to enhance service delivery.
- Closed FDA Data Integrity warning letter by remediating 600+ GMP, metadata instruments and achieving 100% CAPA on-time closure rate.
- Delivered Data Integrity KPI dashboards and authored SATr procedures to ensure compliance with CFR Part 11 and EU Annex 11 standards.
- Oversaw LIMS/Empower platforms for GxP instruments, ensuring compliance and readiness for risk-based inspections.
West Coast Supply Chain Business Manager
VWR INTERNATIONAL, INC.
Radnor
02.2012 - 09.2015
- Developed supplier scorecards to drive performance accountability, leading to consistent positive P&L results through effective asset management.
- Managed validation services for North American clients, delivering CQV/calibration support to ensure compliance and operational excellence.
- Delivered CQV and CAL services at point of sale, improving customer satisfaction and fostering repeat business.
Director Quality Control
AFFYMAX, INC.
Palo Alto
04.2008 - 12.2011
- Directed stability studies, analytical method validations, and tech transfers for NDA-CMC submissions, facilitating timely EPO-Hematide approvals.
- Managed QC HPLC, GC, and peptide laboratory testing, method validations, and equipment qualifications, ensuring compliance with regulatory standards.
- Contributed expertise as SME on global CMO and internal audits, leading to 100% audit success through effective cross-functional collaboration.
Quality Control Director
CHOLESTECH CORPORATION
Hayward
04.2006 - 04.2008
- Led 12-member QC team in achieving ISO 13485 certification for diagnostic device manufacturing.
- Enhanced first-pass lot release rates to 90% and minimized NCRs through implementation of JMP-based risk assessments.
- Led MRB to assess product disposition and oversee recall of quarantined items per FDA QSR compliance.
Senior Manager of QC Validation
VaxGEN INC.
SSF
05.2004 - 05.2006
- Oversaw quality of rPA protein DS and DP method validation for DOD’s Anthrax and Smallpox vaccine development, supervising three FTEs in VaxGEN’s post-9/11 in-house manufacturing startup, and documenting method transfers and validations for microbiological techniques, aseptic processing, and raw material testing.
- Managed QC validation for DOD Post-911 vaccine program, validating analytical methods and commissioning new lab suites to support vaccine development.
- Completed CQV and assigned analytical method validations, ensuring compliance with regulatory standards.
QC Manager
BAYER Biologics
Berkeley
04.1993 - 05.2004
- Supervised release of cGMP host contaminant assays for QC final product and optimized equipment qualification for final release assays in QC development group.
- 1999 to 2004: QC Manager
- Developed commercial final product BLA release qPCR DNA assay, replacing DNA hybridization and drafting regulatory BLA amendment; ensured successful equipment qualification for QC department.
- Oversaw LIMS implementation to Trackwise, facilitating reporting of deviations and CAPA.
- 1993 to 1996: Pilot Plant Mfg Process Scientist
- Resolved pilot scale fermentation and purification failures, freeze-drying, formulation composition and purification process optimization at the pilot scale of truncated tICAM, recombinant Factor VIII:c and plasma IgM production in an aseptic commercial environment.
Education
Master of Science - Biochemistry
Michigan State University
Bachelor of Science - Clinical Chemistry
Michigan State University
MT (ASCP) - Clinical CA-MT
Skills
- Veeva QMS and LIMS/Empower
- Data integrity and compliance
- GxP and Annex 11 adherence
- Audit and risk management
- Supplier quality assurance
- KPI metrics analysis
- JMP statistical analysis
- 21 CFR Part 11 compliance
- Validation and qualification processes
- CAPA and deviation management
- AI-driven data analytics
- Independent work capability
Patents Publications And References
Upon request
License And Certification
Lean Six Sigma Green Belt, Lean Six Sigma Global Institute
Timeline
Head of Quality Assurance/Quality Control– Consultant to CEO
MARIN BIOLOGIC LABORATORIES
10.2025 - Current
Quality Assurance Compliance Manager, System Administrator Contractor
EXELIXIS THERAPEUTICS
10.2024 - 05.2025
Quality Assurance-Data Integrity Senior Director Consultant
TRAVERE THERAPEUTICS
11.2022 - 11.2024
Senior Security Advisor Consultant to the CEO
YULON Capital LLC
09.2018 - 03.2023
Owner/Principal
WDANG COMPLIANCES SERVICES
09.2015 - Current
Associate Director of Managed Services Contractor
GILEAD SCIENCES
09.2015 - 12.2018
West Coast Supply Chain Business Manager
VWR INTERNATIONAL, INC.
02.2012 - 09.2015
Director Quality Control
AFFYMAX, INC.
04.2008 - 12.2011
Quality Control Director
CHOLESTECH CORPORATION
04.2006 - 04.2008
Senior Manager of QC Validation
VaxGEN INC.
05.2004 - 05.2006
QC Manager
BAYER Biologics
04.1993 - 05.2004
Master of Science - Biochemistry
Michigan State University
Bachelor of Science - Clinical Chemistry
Michigan State University