George Kuniholm
Senior Director, Head of Quality Assurance
- Role
- Senior Director, Quality Assurance at Olema Oncology
- Location
- Novato, CA, US
- LinkedIn followers
- 500 followers
About George Kuniholm
Seasoned expert in Life Science industry with both leadership and a hands on approach. Frequently applied skills include Supplier, Internal and Corporate audit oversight; pre-approval and routine inspection oversight with exposure to multiple inspectorates, commissioning and validation oversight, quality systems and training oversight, and pharmacovigilance oversight. Applications include Biologics, Oral Solid Dosage, Gene Therapies, Autologous cell Culture Laboratory, Medical Devices, Microbiological and Analytical Laboratories. Thorough understanding of GMPs, GCPs, GLPs, GVPs and Part 11 / Data Integrity. Team player focused on advancement of the organization.
Experience
Senior Director, Quality Assurance
Jan 2025 — Present · San Francisco, CA, US
GxP inspection readiness, Leading and managing regulatory inspections in collaboration with internal and external partners, general oversight of audits and preparation of the audited entities for inspection. Oversee the development and automation of the Quality Management Systems. Oversight of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions, and implementing Quality by Design, Quality Metrics / KPI. Development of a high performing team of professionals to ultimately bringing meaningful medicines to patients.
Education
RPI Lally School of Management
MBA, Manufacturing, Logistics, Quality
1990 — 1992
Amherst College
BA, Biology, English
1984 — 1988
Skills
- Standard Operating Procedure (Sop)
- Quality Management
- Quality Assurance
- Computer System Validation
- Pharmaceuticals
- Lifesciences
- Gmp
- Life Sciences
- Gxp
- Quality Auditing
- Validation
- 21 Cfr Part 11
- Process Improvement
- Technology Transfer
- Documentation
- Iso 13485
- Cgmp
- Cross-Functional Team Leadership
- Quality System
- Quality Systems
- Biotechnology
- Document Management
- U.s. Title 21 Cfr Part 11 Regulation
- Medical Devices
- Iso
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Capa
- Good Clinical Practice (Gcp)
- Gcp
- Biopharmaceuticals
- Corrective and Preventive Action (Capa)
- Software Documentation
- U.s. Food and Drug Administration (Fda)
- Change Control
- Compliance
- Auditing
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