As Overarching Project Lead you are leading a group of highly skilled QRM experts and defining and aligning global cross-functional strategies regarding QbD and QRM development approaches. Furthermore your are representing the Drug Product (DP) team for a specific project and are responsible for activities related to drug product development and/or lifecycle management, while considering legal requirements for pharmaceutical manufacturing in parenteral drug product development.

Your responsibilities are: 

• Leadership of Overarching Project Group within pPDS&T Drug Product Ludwigshafen including development and alignment of overarching development strategies as well as related framework and infrastructure in strong collaboration with partners and Representation of parenteral PDS&T organization in global project teams as DP Lead
• Education and training of employees and pharmaceutical personnel in particular with regard to QbD approaches
• Responsibility in developing globally aligned, standardized, QRM-based development approaches for parenterals in cross functional settings.
• Development, management and and guidance in the execution of global goals and initiatives to improve parenteral development and QbD strategies.
• This includes the development of technical project plans and timelines aligned with quality risk management principles, effective communication of project status and risks, and clear, appropriate presentation of data and strategies in alignment with regulatory expectations.
• Creation and approval of GMP-compliant and regulatory documents (such as IMPD, IND, CTD for clinical trials, and BLA, NDA, PAS for market submissions)