Philip Rose has over 20 years of experience in a wide range of roles within the pharmaceutical industry, from QC through to senior management and as a Qualified Person. Most recently, he worked as a Lead Senior GMDP Inspector for the UK competent authority the MHRA. Within this role, he inspected some of the most complex cases globally against EU GMP and GDP in areas such as biologicals (including vaccines), steriles, non-steriles, ATMPs and specials. This included inspections on behalf of the EMA as well as leading joint inspections with the U.S. FDA. Mr. Rose was a member of the MHRA’s Compliance Management Team (CMT) and was the Inspectorate technical lead for biologicals and, previously, the technical lead for steriles. He was also a member of the Inspectorate’s cross-contamination group. Mr. Rose recently served as a key member of the MHRA’s Vaccine Task Force involved in the UK’s COVID-19 response.
Recognized Expertise Includes:
- Manufacture of biologicals, steriles and non-steriles
- Good Manufacturing and Distribution Practice
- UK specials
- Inspection readiness and remediation
- Regulatory compliance
- Global auditing
Mr. Rose has wide-ranging skills across many dosage forms, including global auditing and inspection readiness. He is fully conversant with current regulations and is able to bring a wealth of experience from working as a regulatory inspector, including as a member of the Compliance Management Team, in addition to time spent within the industry.