Harry Berlanga BSc(Hons) MSc CBiol MSB

Senior Director, Quality, EMEA

Key roles and responsibilities

  • Lead the EMEA Quality function across the Clinical Trials Division at Thermo Fisher Scientific.
  • Oversee the Quality function for 6 sites specializing in the Manufacture, Packaging and Distribution of Investigational Medicinal Products (IMPs).
  • Provide leadership on Quality and Regulatory aspects of Clinical Packaging and Supply chain
  • Specialist UK/EU Qualified Person knowledge

Professional highlights

  • Full Eligibility to act as UK/EU Qualified Person
  • Chartered Biologist of the Royal Society of Biology
  • Member of the Research Quality Assurance GMP Committee
  • Over 20 years’ industry experience in Steriles, Biologics & Solid Dose in both Commercial and Clinical Manufacturing and Packaging. Speaker at numerous conferences on Quality and Regulatory aspects of Clinical Supplies
  • IRCA accredited Lead Auditor with extensive GMP audit experience

Education

  • BSc (Hons) Biomedical Sciences
  • MSc Pharmaceutical Sciences
  • Currently undertaking MSc in Strategic Quality Management (completion 2023)

Scientific expertise

  • Qualified Person Activities
  • Quality Leadership
  • Regulatory Pharmaceutical Sciences
    • Clinical Regulatory and Quality
    • Bulk and Vial Sterile manufacture
    • Solid Dose Manufacture and packaging
    • Microbiology and Environmental monitoring

Related Sites

Additional Resources