Andrew Hare
Director @Hare Analytical Ltd
Signup · Get unlimited contacts
WORK HISTORY
Director @Hare Analytical Ltd
Founded consultancy offering QA and GMP compliance solutions to ATMP, biologics and API manufacturers. Clients include Imperial College, Quell Therapeutics, Kings College London, Ascend Therapeutics, and Ransom Naturals.Led PQS remediation for MHRA inspection findings (Imperial College)Developed eQMS frameworks and validation packages for GMP readiness (AAV facility buildout)Acted as Interim Head of Quality, overseeing licensure maintenance and regulator liaisonDelivered QMS maturity assessments, SOP development, training (Six Sigma Yellow Belt), and supplier auditsSpecialisms: Inspection Readiness | QMS Development | Validation | Clinical Manufacturing QA | Vendor Oversight | GxP Training
EDUCATION
University of the west of scotland
Bachelor of Science (BSc), Industrial chemistry with placement
ABOUT ANDREW HARE
Quality Assurance leader with over 24 years’ experience supporting advanced therapies, biologics, and small molecules across global GMP/GDP/GCP environments. I provide pragmatic, risk-based compliance strategies that ensure regulatory readiness (MHRA, EMA, FDA) and inspection resilience.As Director of Hare Analytical, I advise on the design, implementation, and remediation of Pharmaceutical Quality Systems (PQS/QMS), vendor qualification, data integrity, and validation (equipment, facilities, and computer systems). My clients range from start-ups to hospital units and established biotechs.Formerly QA Director/Manager at bit.bio, Freeline, Adaptimmune and GSK, I bring deep leadership experience in matrix teams, audit management, continuous improvement (Six Sigma Green Belt), and ATMP tech transfer.Trainee QP | IRCA Lead Auditor | PQS Transformation | Coach & Mentor | GMP Clinical & Commercial
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.