Georgeta Puscalau
Senior Vice President Quality @Tune Therapeutics
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WORK HISTORY
Senior Vice President Quality @Tune Therapeutics
EDUCATION
Gheorghe Asachi Technical University of Iași
B.S (M.S), Chemical Engineering
ABOUT GEORGETA PUSCALAU
Strategic and results-driven Quality executive with over 25 years experience in biotechnology and pharmaceutical industry. Successful in combining quality, regulatory, technical and project management expertise during product development through the commercialization phase. Recognized for building and transforming the quality culture across multiple organizations, effectively building high performing Quality teams, leading complex integrations and delivering compliant GxP systems. Extensive expertise across gene therapy, cell therapy, biologics, medical device-biologics combination product, and small molecule drug products. AREA OF EXPERTISEQuality Strategy and Governance - GxP (GMP, GCP, GVP, GDP) Compliance - Regulatory Submissions (IND, IMPD, BLA, NDA, MAA)- Inspection Readiness and Health Authority Engagement - Quality Systems Design and Transformation - Global Quality Operations - Consent Decree Remediation - Risk Management - CMO/CRO Oversight - Organizational Leadership and Talent Development - Organizational and Quality System Integration
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