Miguel Chavarria
Principal Global GMP Compliance Expert
- Role
- Principal Global Gmp Compliance Expert at Genentech
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Miguel Chavarria
Results-oriented Biotech Quality Assurance Executive with 23+ years of broad technical and manufacturing experience, including proven ability to effectively lead strategic initiatives and implement at the tactical level.• Director of Quality Assurance responsible for Drug Substance, Drug Product, Quality Systems and Product Complaints, leading and providing direction to a team of Quality Assurance professionals• Strengths include Team Leadership, QA and GMP Expertise, Process Engineering, Computer System Validation, Six Sigma, Facility Commissioning and Qualification.• Successfully and collaboratively managed Quality teams in multiple geographies at Genentech and Eli Lilly to launch new antibody-drug-conjugate molecule as well as manufacture drug substances for commercial supply, including all activities needed for successful FDA and EMA Pre-Approval Inspections.• Site Quality Lead responsible for managing internal and external teams to perform the Tech Transfer of Drug Substance for Merck’s key multibillion-dollar biologic drug from CMOs. • Experience in small-molecule and large-molecule manufacturing.Specialties: Six Sigma Black Belt CertifiedRegistered Professional Engineer; Certified Project Management Professional (PMP)
Experience
Principal Global Gmp Compliance Expert
Mar 2022 — Present · South San Francisco, CA, US
Education
Georgia Institute of Technology
Bachelors, Chemical Engineering
The Johns Hopkins University
Masters, Biotechnology
University of North Carolina at Charlotte
Master of Business Administration (M.B.A.)
Skills
- Process Improvement
- Quality Assurance
- Biopharmaceuticals
- U.s. Food and Drug Administration (Fda)
- Technology Transfer
- Quality System
- V&V
- Process Simulation
- Gmp
- Chemical Engineering
- Validation
- 21 Cfr Part 11
- Standard Operating Procedure (Sop)
- Capa
- R&D
- Biotechnology
- Process Engineering
- Six Sigma
- Change Control
- Root Cause Analysis
- Computer System Validation
- Corrective and Preventive Action (Capa)
- Pharmaceutical Industry
- Sop
- Fda
- Cross-Functional Team Leadership
- Manufacturing
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