Senior Manager, CQA Auditor

Job Title: Senior Manager, CQA Auditor

Location: Morristown, NJ  

About the Job

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

This position will be focused on assessing GCP Compliance in clinical related activities and supporting the Quality Management System to minimize risk.  Responsible for the preparation, initiation, conduct, and follow-up of audits as assigned by CQA Management. 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.

Further responsibilities include coordination and management of inspections, the preparation of Transversal Quality Reviews (service provider / process), and support for project / study QRs as per need.

About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
 

Main Responsibilities:

• 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 preparation of Transversal Quality Reviews (service provider / project process), as assigned by CQA management.  May be asked to support project / study QRs in relation to audits conducted on the program.

• 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.