Omar Craviotto

Associate Director of Quality Systems and Compliance @Sutro Biopharma, Inc.

Vallejo, CA, US
EMAILS
o••••••••@sutrobio.com
MOBILE NUMBERS
+19•••••••91

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WORK HISTORY

Nov 2023 — Present

Associate Director of Quality Systems and Compliance @Sutro Biopharma, Inc.

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San Francisco, CA, US

EDUCATION

2009 — 2012

California State University, Bakersfield

Masters, Education

2003 — 2005

University of Phoenix

Bachelors, Healthcare Management

1995 — 2001

Solano Community College

AS, Biotechnology/Biology

SKILLS

PcrProcess ImprovementManagementLife SciencesValidationBiotechnologyProtein PurificationTechnology TransferStrategic PlanningCapaEvent PlanningManufacturing21 Cfr Part 11Microsoft ExcelPowerpointCross-Functional Team LeadershipMicrosoft WordTeam LeadershipHplcPublic SpeakingChromatographyQuality SystemMolecular BiologyChange ControlSoftware DocumentationU.s. Food and Drug Administration (Fda)BiopharmaceuticalsEmployee TrainingGmpTeachingQuality AssurancePharmaceutical IndustrySopFdaBiochemistryStandard Operating Procedure (Sop)Microsoft OfficeLifesciencesPurificationLeadership

ABOUT OMAR CRAVIOTTO

Experienced and results-oriented Director of Quality Systems and Compliance with a strong background in GMP manufacturing. I bring over 20 years of experience across early- to late-stage biopharma environments, specializing in the design, implementation, and oversight of robust Quality Management Systems that ensure compliance, support scalability, and enable patient safety. My experience includes extensive validation activities and expertise in downstream purification processes, ensuring consistent product quality and regulatory adherence throughout manufacturing.My expertise spans clinical and commercial GMP operations, with a deep understanding of biologics manufacturing, aseptic processing, and cell free production. I’ve successfully led cross-functional teams through regulatory inspections (FDA, EMA, MHRA), internal audits, and large-scale quality system buildouts in fast-paced, science-driven organizations.I’m passionate about building quality frameworks that are both compliant and agile—fit for innovative biotech pipelines and the realities of modern manufacturing.If you\'re advancing biotech innovation and need strong quality leadership to scale with compliance, let’s connect.

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