Do you have experience with internal audits? In audits of third parties (clinical trial sites, external vendors, CROs…), regulatory agencies inspections & sponsor audits ? Then we've got THE job for you!
Job description
The Compliance and Audits manager's primary mission is to provide assurance to the Directors that clinical trials and projects are meeting the utmost level of quality internally and externally, required per applicable processes and regulations.
Responsibilities
Audits of third parties
- Develops and implements an annual audit program using appropriate risk-based methodology, including any risks or concerns identified by HQ staff involved
- Performs external vendor audits and follow-up on CAPAs across Europe (4-5 audits/year)
- Coordinates audits conducted by consultants on behalf of the client as applicable
Internal Audits
- Responsible for designing and managing the internal audit process to ensure compliance with professional auditing standards
- Performs internal audits, including preparation, conduct , reporting and follow-up of the CAPAs
- Escalates, as appropriate, where resolution of audit findings is inadequate or where SOPs/process improvement might be advised
Inspections and audits of the client
- Ensures preparation and representation of the client during sponsor audits or Health Authorities inspections
- Ensures appropriate communication of audit/inspection findings to Heads of Units/ Departments and follow-up of actions until CAPA closure
General
- Provides support and advice to the client staff and partners in case of GCP issues
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
Profile
- University degree or equivalent in Health Sciences or relevant field
- Thorough knowledge, understanding and experience applying ICH GCP Guidelines
- 4+ years or relevant clinical research experience which includes at least 2+ years of GCP auditing experience
- Experience with clinical CAPAs
- Excellent presentation and communication skills
- Excellent organization and planning skills and attention to detail
- Ability to work independently and within a team
- Proactive, dynamic
- Ability to travel across European countries (10-15 days a year)
- Fluent in English (oral and written), any other European language is an asset
Benefits
- A balanced salary package based on your capabilities and experience, including meal vouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 17047
