Are you looking for an exciting opportunity to shape the quality strategy for device development projects? We are seeking a highly motivated Device development QA Project portfolio Manager to play a vital role in ensuring the quality and safety of our products for clinical trials.
Don't miss this chance to make a significant impact in a dynamic and innovative industry. Apply now for a life-changing opportunity!
The position
Due to an increasing project portfolio, we are expanding and looking for a new colleague who is experienced and skilled in Project portfolio management from a QA point of view. You will be part of our team and cover the quality perspective in multiple device development projects across DMD (Device Manufacturing Development), working in close collaboration both with the management group consisting of 3 managers and 1 director, the team of 12 project QAs and of course our stakeholders in Line of business (LoB).
In this role, you will manage the broader quality perspective across multiple projects with high complexity and help build the best process, system and governance to maintain overview of progress and quality risks. You will get a broad range of exciting challenges with an impact on the results for the CVP area feeding into your personal and professional development.
Other than drive, coordinate, and facilitate QA resource estimates overview across multiple projects, quality-related activities between LoB and QA incl steering group meetings, project risk overview, strategic Quality direction and document reviews, main responsibilities will be to:
Identify and contribute to strengthening and simplifying our working processes with projects in DMD QA
Foster collaboration with our stakeholders
Have an impact on defining own role and tasks
Take important decisions and oversee the quality of projects going into clinical trials
Contribute with review and approval of documents
Overall, this is a great opportunity to make a meaningful impact in the pharmaceutical industry and help drive the development of high-quality products. We maintain the product responsibility until end of life cycle so you will also have a unique opportunity to keep up with the products impact on our patients.
Our working environment is flexible, dynamic, and informal with a strong culture of cross-functional collaboration.
Qualifications
To succeed in this role, we imagine that you:
Hold a master’s degree in pharmacy, biotechnology or similar
Have proven solid experience with project portfolio management/coordination
Have solid experience from pharmaceutical companies
Have profound knowledge of the important aspects of QA and GXP relevant regulations, requirements and guidelines for Devices and pharmaceutical development for clinical trials
Are fully proficient in English
As a person, you are structured, keen on having the holistic overview, open-minded, quality- and goal-oriented. You thrive in having the opportunity to make decisions and you are eager to find systems and solutions to complex challenges, efficiently setting up processes and structure that creates overview and thrive working in a dynamic environment, where teamwork is on the top of the agenda.
Managing a large network of people is something that drives you and succeed in this by utilizing your great collaboration and communication skills on all organizational levels and are a self-driven and independent person with a high sense of responsibility and initiative.
About the department
At DMD QA, we are a department of 42 highly qualified professionals based at our site in Hillerød, with diverse backgrounds and interests. In team Product development QA we are 12 highly skilled professionals waiting for you to join us.
We are responsible for ensuring the quality and compliance of all processes in DMD, including product development and life cycle management, design control, testing and producing for clinical trials phase 3.
We take pride in our work and are constantly seeking to improve our competencies and processes through a focus on simplicity and collaboration. By joining our team, you will have the chance to make a real difference in the lives of patients through the development and life cycle management of crucial medical devices.
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