Olga Minkov
Global Operations Executive & GxP Quality Architect • Building High-Performance Teams in Regulated Environments • AI Strategy for Life Sciences • Former Global Pharma VP
- Role
- Medical Operations at Ssi Strategy
- Location
- Naples, FL, US
- LinkedIn followers
- 500 followers
About Olga Minkov
I have built my career in drug development operations, with a focus on pharmacovigilance, GxP compliance, quality management, and inspection readiness. Before consulting, I held executive leadership roles in global pharmaceutical organizations and now serve as a senior advisor to growth stage biotech and pharma companies.I have found that quality risk can often be obscured by incomplete measures. A key part of my advisory work is helping leadership teams draw a meaningful distinction between metrics that track operational activity and KPIs that reflect true quality performance. This shift gives organizations a more accurate line of sight into what actually matters.More recently, my work has expanded to the intersection of AI and GxP. I partner with companies to connect emerging AI capabilities to existing compliance frameworks and to evolve risk assessment approaches as AI becomes embedded across clinical, commercial, and patient facing functions.
Experience
Medical Operations
Jan 2024 — Present
Senior advisory and operational strategy across pharmacovigilance, GxP compliance, and quality management for growth stage biotech and pharma clients. Work spans system design, inspection readiness, executive advisory, and AI governance in regulated environments.
Education
Keller Graduate School of Management of DeVry University
MPM, Project Management
1994 — 1997
University of Illinois Chicago
BS, Biology, Chemistry
1987 — 1991
Skills
- Program Management
- Strategic Sourcing
- Vendor Management
- Clinical Research
- Quality System
- Quality Systems
- Integration
- Operational Strategy
- Leadership
- CRO
- Standard Operating Procedure (Sop)
- Contract Negotiations
- Business Process
- Strategy
- Clinical Development
- Outsourcing
- Edc
- Ctms
- Oncology
- Management
- Mergers & Acquisitions
- Strategy Development
- Cross-Functional Team Leadership
- Gcp
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Clinical Operations
- 21 Cfr Part 11
- Pharmaceuticals
- Good Clinical Practice (Gcp)
- Pharmacovigilance
- Mergers
- Contract Negotiation
- Clinical Trials
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