Risk Management
Preparation for and ensuring successful regulatory inspections
Management of supplier changes and quality continuity
Context and key issues
agap2 Life Sciences is involved at the Sanofi Aramon site, which specializes in the manufacture of chemical active pharmaceutical ingredients (APIs), to strengthen the Quality Assurance team amidst high regulatory stakes and organizational changes. This mission comes at a strategic time, marked by preparation for upcoming regulatory inspections (FDA, ANSM), the deployment of new digital quality tools, and a need for managerial continuity within Quality Assurance during the interim period of the Quality Director. In this context, agap2 was brought in to support the QA Compliance Manager, with a gradual increase in responsibility towards an expanded scope including QTP-type missions.
Site risk assessment and prioritization (data collection, analysis, scoring)
Definition and monitoring of risk mitigation plans
Management of actions resulting from audits and inspections, including the drafting of official responses
Management and reporting of the Site Risk Profile
Execution of and support for Risk Based Impact Assessments (RBIA) according to Sanofi standards
Supplier Technical Quality Management and deployment of Global actions
Immediate strengthening of regulatory compliance and effective preparation for inspections.
Risk visibility and structured action plans presented to the Executive Committee.
Responsiveness to supplier changes and control over analytical and operational impacts.
Discover other high-stakes assignments where our expertise in engineering, project management, quality, or supply chain has enabled us to turn constraints into concrete results.
