Thomas Warren
Sr. Director, Quality Assurance at ARMR Sciences, Inc.
- Role
- Sr Director, Quality Assurance at Armr Sciences Inc
- Location
- Union City, CA, US
- LinkedIn followers
- 500 followers
About Thomas Warren
I have over 17 years of biotech manufacturing and QA experience in large pharmaceutical companies as both a manager and individual contributor. I currently am QA focused on external partner collaboration and help my larger group to oversee all QA aspects of making and releasing our product. Specialties Include:• Regulatory and Compliance: Experienced with cGMPs and regulatory audits • Manufacturing Equipment & Troubleshooting: Technical Expert/Trainer for equipment and cell culture processes• Quality Systems: Owned Deviations (non-conformances), Change Controls and was Mfg expert for Inventory Systems (MES/SAP)• Development: Created Key Performance Indicators to improve Mfg Processes and Personnel• Document Coordination: Creator/Reviewer for SOPs and Manufacturing Batch Records• Cross Functionality: Worked with all departments cross functionally to ensure smooth production• Knowledge: Environmental Monitoring and Cell Culture Processes
Experience
Sr Director, Quality Assurance
Aug 2025 — Present
Education
UCLA
Bachelor of Science (BS), Communication, General
1997 — 2001
Skills
- Vaccines
- Medical Devices
- Capa
- Aseptic Processing
- Biotechnology
- Technology Transfer
- Quality System
- Computer System Validation
- Gcp
- Biopharmaceuticals
- Change Control
- Validation
- Gmp
- Pharmaceutical Industry
- Sop
- Fda
- 21 Cfr Part 11
- CRO
- Manufacturing
- Process Improvement
- Cgmp Manufacturing
- Clinical Development
- Regulatory Affairs
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