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Project Manager Qualification and Validation

qbdbv

AntwerpenHybrid1y ago

About the role

🔍 Project Manager Qualification & Validation

📍 Location: Hybrid
🕓 Type: Full-time

QbD Group team 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’s in it for you?

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued.

🏢 What you’ll be doing

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.

💪 What you bring

  • 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.
  • You have a good understanding of Annex 1 guidelines for validation purpose.
  • 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.

🫵 Who you are

Our culture is driven by values If this sounds like you, you’ll fit right in:

  • You’re resilient and tackle challenges with a positive mindset
  • You’re curious and always up for learning something new
  • You have a no non-sense approach honest, clear, respectful
  • You’re innovative and bring ideas, not just opinions
  • And above all, you’re serious about your work, but not too serious about yourself

✨ About us

We support life sciences companies from idea to patient — offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.

We believe in JPEG:
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.

📩 Interested? Let’s talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family

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