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