Administration? Or project leadership? It’s your choice.
While excellent project and multiproject management is crucial for succeeding in pharma R&D, the real key is adapting to your organization.
Let us define the project management system and the tools needed to give you success. Let us determine, implement and monitor your unique project management culture.
I believe that success is rooted in how projects are chosen, prepared, and managed. This includes all the required reporting processes, tools, templates and explicitly defining the decision-making criteria. Among the questions I will ask are: How is your multi-project management organized? Who oversees all projects, and defines and sets their priorities and allocates ressources? How do you organize and keep workflow transparent? And finally, How are roles and responsibilities decided on and clearly defined?
Project management is also quality management. It is business excellence, it includes aspects of IT, technology transfer, leadership, structure and more. It requires looking at “cross”-priorities, project controlling and information management. And it all boils down to a few simple questions: Do you get all data you need on time, every time? Are you making the right decisions at the right time? Do you have an overview of everything that is going on?
Start your genuine and effective project management.
Quality is a mindset.
Active quality management is a culture, a complex multidimensional integration of people, leadership, processes, and hardware.
It is not limited to products, but touches every process and service.
Quality Management requires excellent leadership, a clear commitment to a set of values and team management, well-structured, functioning systems, links and interfaces, and tools which transform policies into practical, detailed actions within a constructive environment. It’s about creating a culture that fits your organization’s values and vision – and much more than a set of guidelines.
Quality Management in R&D aims to combine:
- Creativity with an open, flexible and somewhat “elastic” mind set
- The shift from a “GMP” to “non GMP” and backwards way of thinking
- Integrating creative, process-oriented thinking with a well-balanced quality mind set
- Performing non-GMP activities, focusing on creative development work
- Constructive “mistake culture” (mistakes as a source for improvements and ideas)
- Fulfillment and pragmatic implementation with the relevant quality guidelines
- Understand the mindset of quality regulations like QbD and other
- Setting up physical (equipment, rooms, hardware) and IT infrastructure
- Assisting in preparing the relevant documentation
- Managing OOS/deviation and change handling
- Defining and implementing changes to your organization’s quality of culture
- Building up and supporting a Quality by Design mindset and quality culture
- Supporting you as external QP
It‘s all about change.
My years of experience in operative pharma product development in a number of different pharma environments has prepared me to support you in whatever way you need.
- Optimization of organization and processes in your R&D
- Consolidation of different sites
- Coordination and optimization of operations between different sites
- Optimization of organization and processes (production, quality assurance, sales, portfolio, business development…)