GK

George Kuniholm

Senior Director Quality Assurance at Olema Oncology

George Kuniholm is an experienced professional in quality assurance and compliance within the biopharmaceutical industry. As of January 2025, George serves as the Senior Director of Quality Assurance at Olema Oncology, focusing on GxP inspection readiness and regulatory inspections. Previous roles include Senior Director of Corporate Supplier Quality Management at AGC Biologics, where responsibilities encompassed global supplier quality and audit programs, and Principal at Cypress Compliance LLC, specializing in GMP, GCP, and GLP audits. George has held various leadership positions at notable companies such as Theravance Biopharma, Gilead Sciences, BioMarin, and Anika Therapeutics, successfully managing supplier quality and regulatory inspections. Educational qualifications include an MBA in Manufacturing, Logistics, and Quality from Rensselaer Polytechnic Institute and a BA in Biology and English from Amherst College.

Location

Novato, United States

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Olema Oncology

Olema Oncology is a biopharmaceutical company developing innovative targeted therapies for women’s cancers. Their lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN), is in development to treat estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema recently initiated a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250. They are supported in their mission by experienced and accomplished scientists and board members, leading healthcare investors and some of the most innovative pharma companies.


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Employees

51-200

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