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 QbDer in Qualification & Validation.
Whats 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 youll 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 youll fit right in:
- Youre resilient and tackle challenges with a positive mindset
- Youre curious and always up for learning something new
- You have a no non-sense approach honest clear respectful
- Youre innovative and bring ideas not just opinions
- And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.
Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family
Project Manager Qualification & Validation Location: Hybrid Type: Full-timeQbD 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 f...
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 QbDer in Qualification & Validation.
Whats 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 youll 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 youll fit right in:
- Youre resilient and tackle challenges with a positive mindset
- Youre curious and always up for learning something new
- You have a no non-sense approach honest clear respectful
- Youre innovative and bring ideas not just opinions
- And above all youre 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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.
Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family
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