Quality Validation Manager IFF (all genders)
Core
Ensure Quality Qualification and Validation activities for a new automated insulin drug substance facility are executed on time and in compliance with regulations.
Role type
Senior IC Quality Validation Manager
Builds
A new fully automated insulin drug substance facility in Frankfurt
Domain
Biopharma / Insulin manufacturing / Regulated industry
Required skills
Quality Qualification and Validation expertise, GxP and health-regulated expertise, Knowledge of biologic product license (BLA) application registration process, Continuous improvement management, Leadership and assertiveness skills
Preferred skills
Experience in Insulin DS processes, International and FDA exposure, Experience with Quality systems
Technologies
QbD approach, Cleaning Validation, Filter Validation, Analytical Validation
Responsibilities
Ensure quality culture, mindset, GMP compliance performance and continuous improvement across all functions and organizational levels across the project and future sites, Serve as Quality Subject Matter Expert (SME) for the project on all matters related to Quality Qualification and Validation, Deliver Quality activities in accordance with IFF planning & project needs including writing, reviewing and releasing documentation considering QbD approach as required, Contribute to the improvement of QMS initiatives to ensure compliance with applicable regulatory requirements and Sanofi quality standards at all times, Develop, update and promote Sanofi Global Quality Documentation and IFF GOPs or Global procedures, Ensure the consistency of turnover packages to system owners, Support execution of project Qualification, Validation strategy and plans as required whilst Collaborate with the facility in China to maintain benchmark standards and share best practices, Actively engage in project team meetings, planning sessions, and related project requirements to ensure effective planning and execution of key Quality Validation deliverables
