SARATH GANDRA
Hayward
Summary
Validation and quality leader with 15+ years of experience in Data Integrity (DI), CSV, and compliance within GMP-regulated environments. Led DI initiatives across multi-site operations, conducted gap assessments, and implemented remediation and periodic review programs aligned with ALCOA/ALCOA+ principles. Skilled in the full validation lifecycle (VMP, URS/FRS, IQ/OQ/PQ, RTM, VSR, SOPs) and proficient with systems such as Veeva, ValGenesis, TrackWise, LIMS, SAP, and CMMS. Frequently serves as DI SME in FDA and QP audits, with strong cross-functional collaboration, audit readiness, and project execution capabilities.
Overview
18
18
years of professional experience
Work History
Senior Manager
4D Molecular Therapeutics
04.2024 - 07.2025
- Led site-wide compliance for GxP software systems supporting MFG, QC, and Tech Ops; ensured adherence to DI and validation standards.
- Acted as program owner for Periodic Review and User Access Review; maintained validated state and data integrity of lab systems.
- Remediated over 1,000 vulnerabilities and implemented automated patch management to support DI and cybersecurity compliance.
- Successfully supported QP audit remediation; contributed to zero findings in follow-up audit.
- Deployed Sapio-LIMS, REES, BMS, JMP, SAS, and Acronis for GMP use; led CSV activities for lab instrumentation and software.
Senior Manager
Sangamo Therapeutics
06.2022 - 04.2024
- Directed GMP lab operations and compliance across validation, asset lifecycle, CAPA, deviations, and change management.
- Owned and executed audit trail reviews and periodic review programs to meet ALCOA+ and regulatory expectations.
- Led validation of instruments, systems, and facilities, aligning with 21 CFR Part 11 and Annex 11 requirements.
- Implemented enterprise systems including LIMS-EM, SDMS, ComplianceWire, and Veeam Backup.
- Managed DI and quality initiatives related to equipment retirement, system decommissioning, and data retention.
- Oversaw CAPEX/OPEX planning, service contracts, and system support for multiple labs.
Project Manager/ Sr, Validation Lead
Gilead Sciences
11.2014 - 06.2022
- Designed and implemented DI policies and procedures (ALCOA+) for lab systems and data workflows across multiple sites.
- Trained cross-functional teams on audit trail reviews, data integrity reviews, and DI compliance strategies.
- Managed curriculum development and OJT frameworks for multiple institution families and locations.
- Led CSV efforts for lab equipment, software applications, and GMP instruments; ensured validated deliverables were complete and audit-ready.
- Oversaw VEEVA migration of 150,000+ quality and validation records; ensured metadata integrity and seamless access.
- Coordinated relocation and qualification of 450+ lab instruments during new facility buildout (B357).
Project Lead
B.Braun Medical Devices Inc
04.2014 - 11.2014
- Collaborated with purchasing, operations, safety, engineering, and IT departments to transfer product design from third party vendor to local site.
- Completed design transfer for new compounder and started batch production on time.
- Trained 35-member assembling team on new product assembly instructions.
- Created new process in shipping and trained associated teams on new process; increased efficiency by 50%.
Validation Lead
Roche Carolina
06.2013 - 04.2014
- Led team in remediation and re-validation of LDAS system, which is a multi-instrument, multi-tasking data application that operates on Microsoft Windows operating environment (ChemStation application /ChemStore Database).
- Effectively presented and defended a new data workflow to FDA auditors, resulting in zero findings.
- Deployed 40 spreadsheets for GMP QC testing; trained QC analysts on how to use spreadsheets in compliant manner.
- Validated Analytical lab instruments and manufacturing equipment per GMP policies and procedures.
Validation Engineer
Shire BioPharmaceuticals
03.2013 - 06.2013
- Designed and performed validation tests, analyzed equipment test results, and corrected quality issues.
- Drafted, reviewed, and executed system impact assessment (SIA), risk assessments (RA), URS, FRS, SAT, IOQ, and PQ documents.
QC Analyst
Hetero Drugs
01.2008 - 05.2010
- Completed qualitative and quantitative analysis of incoming raw materials (API's & excipients) using HPLC, GC, and UV-Vis following standard operating procedures.
Education
Master of Sciences - Pharmaceutical Sciences
The University of Toledo
05.2013
Skills
- Data Integrity
- ALCOA/ALCOA
- CAPA/Deviations
- CSV/CSA
- Equipment Validation
- Periodic Reviews
- Security Audit Trail Reviews
- Regulatory Audits
- Trainings
- Change Management
- 21 CFR Part 11, 210, 211, 820
- EU Annex 11
Timeline
Senior Manager
4D Molecular Therapeutics
04.2024 - 07.2025
Senior Manager
Sangamo Therapeutics
06.2022 - 04.2024
Project Manager/ Sr, Validation Lead
Gilead Sciences
11.2014 - 06.2022
Project Lead
B.Braun Medical Devices Inc
04.2014 - 11.2014
Validation Lead
Roche Carolina
06.2013 - 04.2014
Validation Engineer
Shire BioPharmaceuticals
03.2013 - 06.2013
QC Analyst
Hetero Drugs
01.2008 - 05.2010
Master of Sciences - Pharmaceutical Sciences
The University of Toledo
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