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Project Manager Quality Assurance (H/F/X)
January 29th 2024
QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient. With more than 450 quality experts, QbD is your partner for advice and support.
Mission Description
- You manage various projects within highly innovative environments in the life science industry. This can range from one large scale project to combining 3 to 4 different projects at the same time.
- You perform a quick scan or a gap analysis and are the end responsible for the report and the debriefing at the client.
- You draft, implement and actively manage project plans and have a continuous overview over the timeline, budget and resources.
- You’ll chair steering committees to report about the project status to the different stakeholders.
- You manage and coach project consultants/team members with a multidisciplinary background.
- As an experienced project manager you take a role as Stand-up Leader and you are responsible for continuous improvement of our PMO and project management tools.
- You draw up, review or approve documentation related to the:
- Implementation of a Quality Management System (ISO9001:2015, ISO13485:2016 or according to ICH Q10/Eudralex Vol.4)
- QMS harmonization for medical device, farma, food, other, …
- Gap remediation towards FDA or EU GMP legislation/guidance
- QA process improvement projects
- GMP, GCP or GLP readiness projects
- Roadmap to CE marking for medical devices or clinical trial submission support
- In short, we rely on you for the successful follow-up and implementation of our most important projects that will further draft the future of tomorrow’s healthcare.
Candidate profile
- You have a master’s degree in engineering, technological, pharmaceutical or chemical sciences (industrial engineer, civil engineer, bio-engineer, industrial pharmacist, biomedical sciences, biotechnology/biochemistry, chemistry or a similar scientific study).
- You have several years of experience with the management of multiple parallel projects and the direction of multidisciplinary project teams.
- You feel comfortable in a position where multi-stakeholder management (clients, team members, involved partners, suppliers) is key for the on-time delivery of projects.
- You have experience in a GMP environment and you are familiar with manufacturing processes and operations, GxP guidelines, ISO regulations… In short, Quality Management Systems have no secrets for you.
- A true QbD’er can be recognised by the following qualities:
- Resilient: Your strong and positive attitude helps you overcome any challenge
- Hungry for knowledge: You are always open to learning
- No BS mentality: you can be straightforward in a respectful way
- Innovative: You are constantly looking for new and better solutions
- (Not too) serious: your job is serious, but you don’t take yourself too serious.
Offer
An attractive and complete salary package:
- A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.
But most of all…
- We offer sustainable careers and meaningful connections
- We are a knowledge based company
- You’ll work for an award winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, …
Our promise to you:
- As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
- Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
- In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Contact Details
Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
https://qbdgroup.com/en/jobs/vacancies/project-manager-quality-assurance/