Manager Auditing (CQA)

De organisatie

Assure adequate SOP and GCP compliance in clinical research activities. Perform study and system related audits according to the agreed upon clinical audit program.

Functieomschrijving

International CQA position
Independently perform audits at investigational sites, CROs , document audits to ensure compliance with regulatory requirements and company policies and procedures. 
Participate in system audits and contribute to process improvement initiatives which relate to clinical development. 
Provide advice to the Clinical development staff in GCP related questions. 
Support in preparing for regulatory inspections in region Europe/ Asia or other inter-national inspections as necessary.

Functie-eisen

University (MSc) or college (BSc) degree 
Fluent in written and spoken English 
Relevant experience (3y) along with experience in the pharmaceutical industry or CRO 
Experience in GCP auditing 
Clear understanding of GCP regulations and knowledge of international and national regulations 
NOTE: This position requires a minimum of 40% international traveling

De organisatie biedt

For more information contact Annet Braakman at annetbraakman@perselectief.nl or by phone 06 55 321 637