IRUBIS GmbH

Pharmaceutical Manufacturing

11-50

Germany

IRUBIS GmbH is a life science tools startup that pioneers real-time bioprocess analytics with mid-infrared (MIR) spectroscopy. Our mission is to revolutionize bioprocess monitoring and control with innovative and user-friendly tools, enabling the next generation of biopharmaceutical production. To support our growth and meet the high standards of our clients, we are building a Quality Management System according to ISO 9001 and ensuring GMP readiness.

## Tasks

*   Establishing and implementing an ISO 9001-compliant QMS
*   Ensuring GMP requirements (esp. data integrity, documentation, software validation)
*   Creating, maintaining, and training quality processes, SOPs, and manuals
*   Preparing and supporting internal and external audits
*   Setting up processes for CAPA, deviations, change control, and supplier management
*   Collaborating closely with internal teams (R&D, Production, Service) and external partners

## Requirements

*   Proven track record in developing and implementing ISO 9001-compliant QMS
*   Solid expertise in GMP environments (pharma, biotech, medtech, or suppliers)
*   Familiar with Annex 11 / 21 CFR Part 11, CSV/CSA approaches, and data integrity (ALCOA+)
*   Hands-on experience with audits and certification processes
*   Pragmatic, structured approach and ability to drive solutions efficiently
*   Strong communication skills in German and English

## Benefits

*   Modern office space: centrally located in Munich
*   Flexible working hours, a great team and flat hierarchies
*   Exciting personal development opportunities
*   Stay fit and energized with EGYM Wellpass access, fruit basket and refreshing drinks
*   Company events: enjoy summer parties, traditional Wiesn visits, and our annual Christmas celebration!

Does it all sound interesting to you? Then send us your curriculum vitae without a personal photo in a PDF document.

Location: Bayerstraße 85a, 80335 Munich

Start time: Flexible

Employee

Professional / Experienced

<p>IRUBIS GmbH is a life science tools startup that pioneers real-time bioprocess analytics with mid-infrared (MIR) spectroscopy. Our mission is to revolutionize bioprocess monitoring and control with innovative and user-friendly tools, enabling the next generation of biopharmaceutical production. To support our growth and meet the high standards of our clients, we are building a Quality Management System according to ISO 9001 and ensuring GMP readiness.</p>
<h2 id="tasks">Tasks</h2>
<ul>
<li>Establishing and implementing an ISO 9001-compliant QMS</li>
<li>Ensuring GMP requirements (esp. data integrity, documentation, software validation)</li>
<li>Creating, maintaining, and training quality processes, SOPs, and manuals</li>
<li>Preparing and supporting internal and external audits</li>
<li>Setting up processes for CAPA, deviations, change control, and supplier management</li>
<li>Collaborating closely with internal teams (R&amp;D, Production, Service) and external partners</li>
</ul>
<h2 id="requirements">Requirements</h2>
<ul>
<li>Proven track record in developing and implementing ISO 9001-compliant QMS</li>
<li>Solid expertise in GMP environments (pharma, biotech, medtech, or suppliers)</li>
<li>Familiar with Annex 11 / 21 CFR Part 11, CSV/CSA approaches, and data integrity (ALCOA+)</li>
<li>Hands-on experience with audits and certification processes</li>
<li>Pragmatic, structured approach and ability to drive solutions efficiently</li>
<li>Strong communication skills in German and English</li>
</ul>
<h2 id="benefits">Benefits</h2>
<ul>
<li>Modern office space: centrally located in Munich</li>
<li>Flexible working hours, a great team and flat hierarchies</li>
<li>Exciting personal development opportunities</li>
<li>Stay fit and energized with EGYM Wellpass access, fruit basket and refreshing drinks</li>
<li>Company events: enjoy summer parties, traditional Wiesn visits, and our annual Christmas celebration!</li>
</ul>
<p>Does it all sound interesting to you? Then send us your curriculum vitae without a personal photo in a PDF document.</p>
<p>Location: Bayerstraße 85a, 80335 Munich</p>
<p>Start time: Flexible</p>


Quality Manager (All genders | Full time | Fixed 6 to 12 months contract)

IRUBIS GmbH logo

Google {privacyLink} and {termsLink} apply.

Benefits

Media

We don't have any open positions at the moment

No available jobs

Offices

Open positions

Values

Videos

Do you have a question?

Spontaneous Application

We’ll send a link to this job to your email.

No time? Just apply later

We are reviewing your account. Once our managers approve it, candidates will be able to apply for this job.

Changes are not visible until you publish your job.

This is a preview of your job ad.

Interested?

The job {jobTitle} was archived or the deadline has passed.

This job is no longer available

Recruiting Team

Our other open positions

We no longer accept spontaneous applications

Are you a talented professional seeking your next career adventure? At {companyName}, we appreciate proactive individuals who can bring a fresh perspective to our team.

While we may not have an immediate job opening that precisely matches your needs, your distinctive experiences and talents might be an excellent fit for us in the future.

To submit your spontaneous application, please use the application form on the right to upload your CV and cover letter. Ensure that you mention your desired position in the cover letter.

Rest assured, our dedicated recruiting team will reach out to you once they identify a role that aligns perfectly with your skills and aspirations.

How to apply

Looking for a job at {companyName}? JOIN works directly with {companyName} to bring you all their open positions. Apply now with JOIN.com.

Jobs at {companyName}. Browse all open positions and become part of our team! Open positions: {jobsCount}

Jobs at {companyName}. Browse our open jobs and join us! We currently have {jobsCount} available jobs. Step up your career and apply today!

Jobs at {companyName}. Browse all our open positions and become part of our team! We have currently {jobsCount} jobs available. Apply today to join us!

Jobs at {companyName}. Browse all open positions and become part of our team! We are currently looking for {jobsCount} additions to our company. Apply today!

Jobs at {companyName}. Browse all open positions and become part of our growing team! We are currently looking for {jobsCount} additions to our company. Apply today!

Jobs at {companyName}. Browse all our open positions and become part of our growing team! We are currently looking for {jobsCount} additions to our company. Apply today!

Browse all our open positions and become part of our team! We are looking for {jobsCount} additions to our company. Take the next step in your career and apply today!

No suitable positions available at {companyName}? Don't wait! Submit a spontaneous job application today and unlock your career possibilities tomorrow.