Senior Director, GCP Quality Assurance

Profile Last Update: 2022-02-10 10:54:43

Auditor Profile

Senior Director, GCP Quality Assurance
Country
United Kingdom
Education
Highest Educational Qualification
Masters Degree
Language(s)
EnglishNative
FrenchIntermediate
SpanishElementary
GermanElementary
Regulatory Framework
EU Regulation
US Regulation
Japanese Regulation
Rest of the World
Auditing Experience
34 Years
Availability Time
Not Available for Hire
Number of Audits performed in the Last 3 Years
As Lead Auditor15 to 30
As Co-AuditorUp to 15
Number of Audits per Category performed in the Last 3 Years
Investigator Sites 12 36.36%
Sponsor System or Process Audits 8 24.24%
Clinical Laboratory Audits (Central/Safety) 2 6.06%
Clinical Laboratory Audits (Biomarker, PK/PD) 0 0%
Investigational Medicinal Product Audit (GMP for IMP) 2 6.06%
Electronic Systems Provider Audit (e.g. eCRF Provider, IVRS/IWRS Provider) 0 0%
Vendor/CRO (Full or Part service) 5 15.15%
For Cause Audits 4 12.12%
GXP Experience
GCP Current Practice
GLP Previous History
GDP Previous History
GMP Previous History
GVP Previous History
IT/CSV Previous History
Geographical Work Area
EU - EEC Yes
USA & Canada Yes
Asia-Pacific Yes
Japan Yes
Investigational Products
Pharmaceutical Product: Chemical Current Practice
Pharmaceutical Product: Biological Current Practice
Adv. Therapy Medicinal Products Not Applicable
Medical Devices Previous History
Consumer Products Previous History
Cosmetic Products Not Applicable
Food Stuffs Not Applicable
Industrial Chemicals Not Applicable
Types of Audits Conducted as Lead Auditor
Investigator Site Audits Current Practice
Sponsor System or Process Audits Current Practice
Clinical Laboratory Audits (Central/Safety) Previous History
Clinical Laboratory Audit (Biomarker, PK/PD) Previous History
Investigational Medicinal Product Audit (GMP for IMP) Previous History
Electronic Systems Provider Audit (eCRF, IVRS/IWRS,...) Previous History
Vendor/CRO (Full or Part Services) Current Practice
Due Diligence/For Cause Audit Current Practice