Kimberly Garko
Executive Level Leader | Quality | Manufacturing | Supply Chain | Chemistry, Manufacturing & Controls |
- Role
- SVP, Chief Technical Officer at Akebia Therapeutics
- Location
- Cambridge, MA, US
- LinkedIn followers
- 500 followers
About Kimberly Garko
Results-driven Chief Technical Officer and Quality Executive with strength in building, innovating, and optimizing global Quality, manufacturing, and high performing supply chain operations teams. Strategic vision to implement risk-based, phase-appropriate lifecycle management practices to advance pipeline development and support commercialization. Extensive experience with inspections by global regulatory authority bodies. Strong capability to partner and collaborate to define, drive, and implement innovative, strategic governance processes at both local and global levels.Biologic, Medical Device, Combination Product & Oral Solid Dose (OSD) Manufacturing Operations Phase I through Commercial | Contract Manufacturing Organization Oversight & Relationship Management | Phase-Appropriate Product Lifecycle and Quality Management | Quality Systems Management | Product Launch Management | Drug Safety and Pharmacovigilance (DSPV)| Phase Appropriate GxP Management | Supply Chain Management | Cold Chain & Logistics Management | Biosimilars & Generics | Single-Use Production Technology | FDA, EU & RoW Regulatory Inspections | Regulatory Submissions | Warning Letter Remediation | REMs Program Management | Viral & Microbial Control Strategies | Product Complaint Management | Research Quality Assurance | ISO 13485 & CFR 210 & 211 | Internal & Self-Inspection Program Management
Experience
SVP, Chief Technical Officer
Feb 2024 — Present · Cambridge, MA, US
Education
Louisiana State University Medical Center
PhD, Virology
1992 — 1999
University of South Florida
MS; BS, Microbiology; Biology
1984 — 1992
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