Head Quality Assurance

Ensuring implementation and monitoring of the Quality systems at Sanofi s External manufacturing sites as per cGMP and Sanofi Global quality document requirements in order to ensure the quality of products delivered to market.

Our Mission :

We Lead and manage the Quality strategy within the External Manufacturing site s network to ensure that drug products manufacturing and distribution activities are in compliance with the Global Quality standards and applicable regulatory requirements.

Main responsibilities :

Digital Transformation :

• Implementing the process and tool at local level in line with the standardized and harmonized approach, including communication, change management, etc as appropriate.
• Providing feedback on the roadblocks and difficulties met related to CoP area supported.
• Providing return on experience on inspection assessing the CoP area supported.
• Proposing evolution for simplification and harmonization of the process and tool.
• Sharing successes and best practices with other sites.
• Contributing to the objectives set via the CoP roadmap.
• Cascade all relevant information to all impacted stakeholders and ensure that the application of the process is well deployed and implemented at entity level when needed to ensure adherence to the standardized approach defined during the CoP
• Act as primary focal point for digital initiatives coming from global
• Promote a performance & data driven mindset, leveraging the power of digital tools
• Ensure the effective use of Digital to transform Quality & Regulatory department operations according to the EM&S digital roadmap to deliver impact.
• Use of digital tool One Quad for Quality KPI reporting.
• Act as SME for Global Digital Transformation

Project Management :

Process Enhancement :

CMO Performance Monitoring :

Quality System Management :

Audits & Risk Management :

Computerized System :

About you :

12 years of experience in Quality Assurance)

Skills Required

Assurance, Manager Quality, Project Management