Bianna Gal

Cell Therapy, Biologics and Pharmaceuticals Quality Assurance Expert 

Career Highlights

  • Quality Systems consultant for biologics, small molecule and combination products

  • Support Biopharmaceutical companies to establish Quality Systems and GMP manufacturing in US and Canada

  • A senior Quality Assurance professional with over 20 years of diversified experience in the biopharmaceutical and pharmaceutical industries

  • Led the Quality Assurance department for successful start of Phase 2B clinical trials in US and EU

  • Developed and implemented Quality Systems to adhere to GMP standards

  • IRX Therapeutics, Director of Quality Assurance

  • Managed day-to-day operations and staff of the quality assurance department

  • Reviewed and approved all validation documents, including test method validation, equipment and facilities validation and process validation, SOPs, change controls, batch records, etc.

  • Developed and implemented internal and external audit programs

  • Developed and implemented Qualification program for the raw material suppliers and contractors

  • Pfizer Global Manufacturing, Pharmaceutical Product Assurance Senior Release Specialist

  • Responsible for site pharmaceutical products release

  • Provided key QA support for the new product launches involving contract manufactured products

  • Performed internal quality assurance audits

  • Performed process, equipment, cleaning and packaging validations

Education

  • BS in Pharmacy: Long Island University

  • St. Petersburg Polytechnic University, St. Petersburg, Russia; Major: Math and Computer Science

  • Fluent in Russian

Connect With Us

Cell One Partners

200 Central Park South

Suite 12Q

New York City, NY 10019

E: info@cellonepartners.com

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