QA/RA Project Manager
DeepHealth
Global Quality Risk Manager
Sanofi
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $125,250 - $180,917 per year
Job Level
SeniorLead
About the role
- Contribute to the design and continuous improvement of Risk management framework with the Business Process Owner, Community of practice and Community of expertise (documentation, training & upskilling, tool application).
- Provide operational support to entities/operations in their risk management activities for a group of sites/entities in collaboration with other QRM managers and Global strategy team for integrated risk management process participating animating risk network.
- Provide extensive expertise on risk management tools (FMEA, HACCP PHA, CM/REM, RBIA) to support business and operational needs to enhance appropriate use of risk management in Quality systems and technical field.
- Lead critical risk facilitation activities when needed and run upskilling/coaching sessions with the risk community, support regular communication regarding risk related topics for the community.
- Utilize data, technology to drive efficiency, facilitate knowledge sharing within defined perimeter to identify and escalate key risks for the company, helping better data driven decisions.
Requirements
- Bachelor's degree with 8-10 years within pharmaceutical; advanced degree preferred.
- Proficient in risk management tools (FMEA, HACCP, process mapping, root cause analysis); previous experience as a QRM champion at site level is highly desirable.
- Strong background in quality risk analysis, quality systems, continuous improvement, and regulatory requirements; familiarity with digital quality systems and data visualization tools (e.g., Power BI) is advantageous.
- Excellent communication and networking abilities, with a strong customer orientation; demonstrated capacity for transversal cooperation and decisive action with a keen sense of priorities.
- In-depth understanding of pharmaceutical quality processes and regulations; familiarity with Sanofi-specific requirements is a plus.
- Project management skills and experience leading cross-functional initiatives in a global pharmaceutical environment are highly valued.
- Languages : English (advanced level oral and written) (required), another language is a plus in particular French (preferred)
