Project Manager Qualification
il y a 3 semaines
QbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD'er in Qualification & Validation.
What do we expect from you as a Project Manager?As a Project Manager Qualification & Validation, you will be responsible for the planning, execution, and delivery of qualification and validation projects within life sciences.
- Lead qualification & validation projects within pharmaceutical, ATMP, and medical device industries.
- Develop and manage project plans, including scope, timeline, resources, and budget.
- Act as the primary point of contact for clients, ensuring alignment on project goals and expectations.
- Collaborate with internal departments (Sales, HR, Division Head) to support business development and resource planning.
- Organize and lead Steering Committees (SteerCo) to report on project progress, risks, and mitigation strategies.
- Ensure compliance with GMP, FDA, EMA, and other relevant regulatory requirements.
- Oversee validation activities including IQ/OQ/PQ for equipment, cleanrooms, utilities, HVAC systems, and processes.
- Support and guide validation specialists, providing coaching and training when necessary.
- Represent QbD Group during internal and external audits.
- BSc/MSc degree in Life Science & Technology, Exact Science, Engineering, or a related field.
- At least 10 years of experience in Commissioning & Qualification (C&Q) within life sciences.
- Fluent in Dutch and English.
- Strong project management skills, with experience managing multiple stakeholders.
- Excellent communication and leadership skills, capable of managing client relationships.
- Problem-solving mindset with a proactive and detail-oriented approach.
- Ability to work independently and as part of a team.
A true QbD'er can be recognized 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 non-sense 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.
- QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
- Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
- As we're a knowledge-based company, you're guaranteed to embark on a continuous journey of learning and development.
- Be part of our global success story. As an award-winning company we value everyone's contribution and celebrate achievements together
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
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
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