Paul Leander

Senior Consultant, GxPAssure

Paul Leander has over 25 years experience in quality and compliance with extensive experience in the field of Cell & Gene Therapy, ATMPs and Biologics.

Paul has extensive experience stablishing audit and quality compliance functions with some of the worlds leading companies: Biogen, Takeda, Merk, Sanofi & BlueBirdBio. 

Paul has a wide range of technical expertise and experience including:

• Apheresis and Cell collection Centres,
• Infusion Sites,
• Drug Product and Drug Substance
• CDMOs,
• Testing Laboratories,
• Raw Material Suppliers,
• Medical Device Manufacturers,
• Packaging Sites,
• Warehouse/Distribution Centres

Paul is experienced in supporting US-FDA inspection readiness and remediation and provides coaching, mentoring, training and support.