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
