職位描述
JOB SUMMARY
Responsible for the initiation, conduct, and follow-up of audits as assigned by CQA Management. Within the frame of the incumbent's mission and responsibilities, the audits and activities require proven ability to independently interact with all internal (e.g., Projects Teams, Operations…) and external (e.g., Vendors / CRO) operational staff involved in the audited clinical research activities. The responsibilities also include the mission of Clinical Project Quality Manager (CPQM) for the projects assigned by CQA Management. Further responsibilities include coordination and management of inspection support, conduct of investigations of Scientific Misconduct and Serious GCP Non-Compliance and the handling of outsourced activities performed by external consultants on behalf of CQA, as required and assigned by CQA Management.
PRINCIPLE DUTIES AND RESPONSIBILITIES
1. Independently manages and performs compliance audits of Contract Research Organizations (CRO), Systems and Clinical Investigator sites for Phase I to IV clinical trials. CRO/Process Project-related audits include external and/or internal processes such as IVRS, central labs, monitoring, data management, filing/archiving, medical writing, GCTM, study start up, DRS etc. Lead both routine and complex directed audits. During Investigator site audits, the incumbent has direct access to subject individual data for records review. He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.
2. Represents CQA on various project/study team meetings. Acts as Clinical Project Quality Manager to provide quality and continuous improvement support at the study/project level. This includes responsibilities such as:
- Follow-up on progress status of assigned project(s)
- Establishment of regular contacts with operational teams
- Advice and consultation on GCP and Quality issues
- Identifying and analyzing potential issues with impact on quality
- Contribution to audit planning / programs and assistance in the monitoring of the implementation of those programs
- Participation in the analysis of results of audits for the assigned projects
- Proposing improvements and/or process changes
3. As requested by CQA Management may represent the sponsor during Regulatory Inspections. This will include preparation, coordination and communication to management. Ensures adequate inspection readiness / preparedness activities in Clinical Development
contributes to inspections as required. Ensures the establishment of effective CAPA, and follows up timely implementation in cooperation with the audited sites, operational units or CRO.
4. In liaison with management, manages cases of Scientific Misconduct and Serious GCP Non-Compliance. Practices and propagates a culture of early issue detection, timely escalation and resolution on an on-going basis. Escalates critical quality risks according to Sanofi policy (RQN).
5. When required, manages clinical auditing activities performed by external GCP QA auditors and assures CQA Management those activities are performed in a timely manner.
6. Assists in the design and participate in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc.
7. Participates in the development, revision, and implementation of CQA Quality Documents, working methodologies, tools and systems. As Sr. Auditor, be able to assess, improve and optimize current process and practice.
8. Provides knowledge updates in areas pertaining to GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/ workshops/symposia.
9. Supports the coaching of less experienced and / or newly hired GCP Quality Auditor(s).
COMPLEXITY AND PROBLEM SOLVING:
Flexibility and willingness to accept frequent travels
Key Internal and External Relationships. Internally, s/he will interact with all relevant functions part of Sanofi CSO Platform or Sanofi Pasteur Clinical Programs / Clinical Sciences and externally with the investigational sites and CROs involved in the clinical research activities. The GCP Quality Auditor will also support investigators and sponsor/monitor’s inspectorate activities. As such, the incumbent may interact with representatives of Health Authorities (FDA, MHRA, PMDA, CFDA, ANSM, EMA, etc.).
職位要求：
JOB-HOLDER ENTRY REQUIREMENTS:
Education and Experience Required:
· Bachelor degree in a life / medical / natural sciences or scientific discipline or equivalent
· Bachelor's degree (advanced degree preferred) plus at least 7 years of experience in pharmaceutical industry or clinical-related discipline including. a minimum of 4 years of Clinical Quality Assurance related experience and / or experience in Clinical Trials, such as Monitoring or Clincial Trial Management with good performance
· Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain (Clinical Development, Pharmacovigilance and Regulatory Affairs)
· Good working knowledge of standard computer office software such as Word, Email system (e.g. Outlook), PowerPoint and Excel
· Good business communication skills in English (orally / in writing)
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 regulatory knowledge
· Ability to propose rigorous, systematic and pragmatic solutions to improve quality system and its level of implementation with innovative approaches
