Senior Project Manager for Validation of Finished Product Processes
1 month ago
Are you a seasoned project manager ready for an exciting opportunity? Do you thrive collaborating in a dynamic environment and are committed to delivering stellar results?
If so, this is you moment. Join us in Device Manufacturing Development (DMD) Assembly & Packaging (A&P) Strategic Support, a team where your impact matters. Seize the chance and apply today
The position
The role of Senior Project Manager for Validation of Finish Product processes in A&P involves close collaboration with manufacturing organizations in Novo Nordisk as well a large portfolio of project teams in DMD. Your primary responsibility is to drive the project quality strategy for establishing and deploying standardized process validation for A&P.
Your key tasks entail:
Coordinating the planning of documents and procedures to support standardization Ensuring documents and templates build on NN validation process from Science- and Risk-based approach to validation are aligned with Fill & Finish Expansion (FFEx) Quality strategy Driving the implementation of clear roles and responsibilities and coordinating training and implementation across programs and projects Collaborating with internal program organisation FFEx and specialists Partnering with validation experts to develop modern approaches to validation that ensure harmonization and simplification across A&P Communicating effectively with stakeholders at all levels to ensure alignment and transparencyQualifications
To be successful in this role, we believe you:
Hold at least a bachelor’s degree in pharmacy, Engineering, Supply Chain, Project Management, or a related field Showcase proven experience working with process validation experts as a project manager in a pharmaceutical manufacturing environment Demonstrate knowledge of external regulations for aseptic products, medical devices and finished products e.g. as anchored in the Novo Nordisk Quality Management System Bring expertise in process validation and regulatory compliance Display proficiency in both spoken and written EnglishExperience working with external partners and management experience are preferred.
As a person, you possess exceptional communication skills, are adept at negotiation, and seamlessly connect with stakeholders. You excel in navigating diverse perspective and orchestrating decisions that align with the best interest of everyone involved. You are not just a team player but also an inspiration, transforming challenging into opportunities for the team’s and business’ success.
About the department
You will join DMD and the A&P Strategic Support team, a key function supporting assembly and packaging of Novo Nordisk finished products, primarily pen injectors and tablets.
We are bridging product development to production and driving development and standardization of new, smarter and aligned processes. Furthermore, we are responsible for establishing assembly and packaging capacity worldwide for new and marketed products in compliance with current regulatory requirements and in close interaction with the Novo Nordisk global production sites. We have an end-to-end presence from device development to production implementation and support to running production.
We are located in Hillerød and are a department that is growing rapidly, consisting of over 150 employees placed into different teams. At the office, we share an informal tone, great work morale and tall ambitions to be the best at what we do. Once you step into this role, you will join a diligent and highly competent team and be at the crossroad between Device and Delivery Solutions, Quality, and Production.
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