Senior GCP Auditor

Our Team

Our mission is to contribute improvement of quality of clinical development through GCP audit and to lead the inspection team to reduce the number of the observation raised during inspections.

The GCP quality auditor:

• Independently manages and performs compliance audits of Contract Research Organizations (CRO), Process Project-related and Clinical Investigator sites for Phase I to IV clinical trials

• Leads the preparation, conduct, and reporting of assigned routine and non-routine GCP audits including Clinical Investigator Site, External Service Provider, and internal Process/System, to assess adherence to corporate standards, study requirements and compliance with applicable regulatory requirements. Non-routine audits may include Due Diligence or for-cause audits.

• During audits, the incumbent has direct access to subject individual data for records review and may have access to unblinded information/data.  He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.

• During the audit, identifies potential issues and risks with impact on the Study, the Project or a specific process. Ensures adequate debrief and communication of these issues and risks.

• Escalates critical issues (i.e. events potentially requiring special risk management measures such as investigational panels) and supports at any subsequent meetings.

• Presents information logically and concisely, both verbally and in the writing of issued reports within the required timelines.  May provide advice and consultation on GCP and Quality issues during audit activities.

• Manages appropriateness of responses, the suitability of CAPA actions, and oversees the delivery of CAPAs actions arising from audits.  Responsible for the escalation of late CAPAs to the Management.

• Leads the coordination and management of pre-inspection preparation visits, provides support to the inspection conduct, may directly host site level inspections, and oversee post regulatory inspection follow-up activities.  Ensures the establishment of proper responses with effective CAPAs and follows up on timely CAPA implementation in cooperation with the inspected sites, operational units or service providers.

• May represent the Sponsor during Sponsor level Regulatory Inspections, as requested by management.

• When required, oversees clinical auditing activities performed by external GCP QA auditors and assures CQA Management those activities are performed in a timely manner.

• Assists in the design and participates in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc.

• Participates in the development, revision, and implementation of Quality Documents, working methodologies, tools and systems related to audit activities.  Influences and persuades to bring about the process and technical improvements.  Support Pre/Post Acquisition activities, if applicable.

• Provides knowledge updates in areas pertaining to Audit and Inspection activities / GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia.  Interprets and applies regulations/ policies to issues, when required.

• Supports the coaching of less experienced and / or newly hired GCP Quality Auditor(s).

Knowledge and Skills:

• Rigor, diplomacy and integrity
• Good analytical abilities and attention to detail
• Ability to communicate clearly and effectively and to foster productive dialog on topics of advance complexity
• Ability to deal with multi-cultural environments
• Capacity to work in team-oriented environment
• Current international regulatory knowledge
• Ability to propose pragmatic and innovative solutions to improve quality systems
• Appetite for and ability to deal rapidly with multiple and new computerized systems and digital tools used in clinical trials (vendors systems, new applications for patients…)

Formal Education and Experience required:

• Bachelor degree in a life / medical / natural sciences or scientific discipline or equivalent
• Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance
• Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain
• Good working knowledge of standard computer office software  
• Good business communication skills in English (orally / in writing)