About The Role

We are working directly on behalf of Eleva GmbH and do not charge any placement fees.

What This Position Has To Offer

📍 Actively shape and develop the pharmaceutical quality system for outsourced GMP activities
🚀 Take responsibility for compliance with regulatory requirements and GMP guidelines in a dynamic environment
🤝 Work in interdisciplinary project teams and represent the QA function to internal and external partners
📈 Contribute directly to quality assurance and ensure the highest standards

Does this sound exciting to you? Then schedule an initial call with us now!! 📞

On behalf of eleva GmbH, we are searching for their next Manager (a) Quality Assurance Outsourced GMP.

Job Summary

Would you like to actively shape and further develop quality assurance for outsourced GMP activities in one of Germany's leading biopharma operations? Then pay attention! 👀

As a recruiting partner of Eleva GmbH, we are looking for you as Manager (a) Quality Assurance (QA) for Outsourced GMP Activities (70-100%), based in Freiburg im Breisgau. 📍

In your role, you will take on a key position in maintaining and further developing the pharmaceutical quality system and ensuring compliance with strict GMP guidelines. You will ensure end‑to‑end Quality Oversight of outsourced GMP activities at CDMOs, including drug substance and IMP manufacturing, analytical testing, and clinical packaging.

Look forward to a responsible role in which you actively operate at the interface between quality assurance and regulatory requirements.

Have we sparked your interest? Then schedule an initial call with us now! 📞 #QualityAssurance #GMP #PharmaJobs #HybridWork

What You Will Be Doing

Maintenance, further development and implementation of the pharmaceutical quality system for outsourced GMP activities
Ensuring compliance with regulatory requirements and GMP guidelines as well as internal SOPs
Creation, processing, evaluation, QA approval and follow-up of deviations, CAPAs and change controls
Execution, creation, review and QA approval of risk analyses
Planning, conducting and follow-up of external audits and internal self-inspections
Creation, review, approval and maintenance of Quality Agreements (QAA)
Representation of the QA function in interdisciplinary project teams
Further development and implementation of quality relevant processes outside the scope of GMP requirements (e.g., process development), ensuring efficient and compliant operations across non-GMP activities.

What You Bring To The Job

Completed scientific or technical degree (e.g. pharmacy, chemistry, biology, pharmaceutical technology, biotechnology, process engineering)
Several years of relevant professional experience in quality assurance, pharmaceutical production or quality control in a GMP-regulated environment
Experience with biopharmaceutically manufactured products (biotechnological production of active ingredients and aseptic manufacturing of medicines)
Sound knowledge of regulatory requirements (e.g. AMG, AMWHV, EU-GMP)
Experience in audit management and supplier qualification
Strong communication and teamwork skills
Willingness to work on-site in Freiburg on a regular basis (at least 50% presence on-site)
English: C1 -- Advanced
German: B1 -- Intermediate

Nice-to-Haves

Experience with electronic QM systems and their implementation

Team

Reports to: SVP CMC/Quality
Colleagues: 3

Benefits

State of the art equipment
Flexible working time models
A pension plan via DYNO
Corporate Benefits/FutureBens
Job ticket from the RVF or Deutschlandticket
Good public transport connections

The team at Eleva GmbH values an open and collaborative way of working. You will be part of an interdisciplinary environment where the exchange of knowledge and experience is actively encouraged. 🤝

Together, you will work to ensure the highest quality standards and develop innovative solutions. Your contribution will be crucial to the success of the team and the company. ✨

Eleva is a clinical-stage biopharmaceutical company developing novel therapies and unlocking difficult-to-produce biologics based on a transformative manufacturing platform.

The company's innovative drug development activities currently focus on complement disorders and enzyme replacement therapies, with wider potential across a range of disease areas.

Eleva offers a workplace that is focused on a valuable goal -- bringing unique therapies to patients in need. Benefits: Pension Plan, Public Transport Remote Model: Hybrid Country Code: de

Manager (a) Quality Assurance Outsourced GMP @ eleva GmbH