Gail Schumacher

Gail Schumacher

Gail Schumacher’s 20 years of hands-on experience in IT Quality Systems Compliance focuses on Risk Based Computer System Validation for F500 pharmaceutical and medical device companies. Her quality assurance expertise encompasses a deep familiarity with international GxP regulations and the application of risk assessment processes to compliance strategies coupled with a fundamental understanding of IT Systems and the Systems Development Life Cycle.

Gail’s professional practice includes compliance oversight, developing and applying electronic data integrity controls and authoring numerous compliance processes and procedures. She is a change agent, leading cross functional teams in quality process reviews, improvement and implementation. Gail also pre-reviews articles submitted for publication to the Institute of Validation Technologies: Journal of GXP Compliance.

Gail is the founder and owner of Schumacher Consultants, assisting IT Quality Assurance and Compliance professionals in the biotech industry.