Darren Brayton
Pharmaceutical Leader
- Role
- Senior Director, Clinical Quality Assurance at Elevar Therapeutics
- Location
- New York, NY, US
- LinkedIn followers
- 500 followers
About Darren Brayton
Hands-on Pharmaceutical Leader with over 25 years of increasing Leadership roles in Quality, CMC, Technical Operations, Manufacturing, Quality Control, and Quality Assurance. Strong technical background in quality and CMC. My approach to making medicine delivers risk-based business solutions for the Pharmaceutical and Medical Device industries. Seasoned Leader who manages risk, builds internal and external customer relationships, and can implement, and manage, an effective and compliant quality system that supports the business CMC objectives. Achieves success by understanding and employing realistic project management philosophies and timelines. Overcomes problems and logistical restraints by leveraging interdepartmental partnerships, balancing science, and compliance, while maintaining Heath Authority Standards. Specialties: Compliance Regulations for: FDA/ICH/Q7-10/IPEC/GAMP/cGMP /GLP/GCP/USP/EU/Medical Device ISO 13485 and FDA 820Quality System Management ISO 17025 Testing & Calibration Lab ManagementInternal Quality AuditorProcess Development and ValidationVendor/Customer RelationshipCompliance AuditsProject ManagementSupplier Audits Quality Risk Management
Experience
Senior Director, Clinical Quality Assurance
Dec 2025 — Present
Education
University of Victoria
BSc, Chemistry
1991 — 1995
Skills
- Quality System
- Gmp
- Quality Assurance
- Quality Control
- Fda
- Validation
- Iso 13485
- Quality Auditing
- Medical Devices
- Regulatory Submissions
- Regulatory Requirements
- Glp
- Quality Management
- Biotechnology
- Pharmaceutics
- Gxp
- Change Control
- 21 Cfr Part 11
- Trackwise
- Technology Transfer
- Pharmaceutical Industry
- Cleaning Validation
- Laboratory
- Dissolution
- Sop
- Capa
- Aseptic Processing
- Analytical Chemistry
- Hplc
- Chromatography
- Deviations
- Contract Manufacturing
- Supplier Quality
- Chemistry
- Microbiology
- Sterilization
- Usp
- Analytical Method Validation
- Deviation Management
- Equipment Qualification
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