Manager QA GMP (m/f/d)

Salary :

€344 - 401 daily

Unternehmen : Tubulis GmbH

Auftragstyp : Vollzeit

Germany

Arbeitsbeschreibung - Manager QA GMP (m/f/d)

Be part of our team

We are a dedicated QA team supporting Tubulis development of antibody-drug conjugates (ADCs) and clinical trials with a strong focus on reliable processes and patient safety. Working closely together, we ensure that quality and compliance are part of every step, from research to clinical application. Our team values open communication, practical problem-solving, and a shared responsibility for doing things right. If you enjoy working in a supportive environment where your contributions make a real difference, we’d be happy to hear from you.

Your mission

Review and QA approval of QA related documents and relevant CMC documents
Review of Batch Documentation (e.g. Master Batch Records, executed Batch Records) of Intermediates (Linker Payload, mAb), Bulk Drug Substance, Bulk Drug Product, Finished Product as applicable.
QA-Approval and follow-up Quality events from GMP relevant vendors (Deviations, OOX, Complaints, Quality Issues, CAPAs, Change Control).
QA release of Intermediates and Sponsor release of Investigational Medicinal Product (e.g. for USA)
Lead compilation of Product Specification Files in collaboration with the respective stakeholders as applicable.
Central QA point of contact at Tubulis for external GMP vendors and partners incl. setting-up, negotiating and revising Quality Assurance Agreements (QAA) with GMP vendors
First point of contact of (external) Qualified Person; compilation and provision of release relevant documentation Organization and/or conduct of audits of GMP relevant vendors incl. follow-up and audit closure
Organization and/or conduct of self-inspections/internal audits (e.g. Mock-Recall)

Your profile

Must-Have Qualifications:

University degree in life-sciences, pharmaceutical science, or engineering with at least 5 years of QA experience in biologics development in Biotech/Pharma industry
QA Experience in working with international CMOs
Experience in implementing GMP Quality Systems
Very good knowledge of international GMP regulations and guidance (EU and FDA regulations)
English fluent, written and spoken

Nice-to-Have Qualifications:

Basic knowledge of ICH GCP and GLP regulations is a plus
Experience with authority inspections (FDA, EMA, MHRA), preparation, hosting, follow-up
Experience as lead auditor or co-auditor of CMOs

Why us?

At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.

Impact that matters: Contribute to breakthrough therapies.
Global mindset: Work in an international, diverse team.
Grow & thrive: Develop your career in a supportive, fast-moving environment.
Innovation every day: Push boundaries with cutting-edge science.

At Tubulis, your ideas matter, your growth matters—and together, we make a difference.

About us

Tubulis is a clinical stage biotech company that generates uniquely matched antibody-drug conjugates (ADCs) with superior biophysical properties that have demonstrated durable on-tumor delivery and long-lasting anti-tumor activity in preclinical models. We recently closed on a Series C fundraising round totaling €344M (US $401M).

The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and ADCs. With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers.

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