Manager QA GMP (m/f/d) bei Tubulis in Planegg (Germany), Remote (Germany), Lausanne (Switzerland)

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

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

Why us?

Flat hierarchies and short decision-making processes; open corporate culture; possibility of mobile working; unlimited contract after probationary period; 30 days' vacation; strong team spirit; personal appreciation of values; multicultural and global team and high level of collegiality; regular team events; mobility allowance; pleasant office atmosphere, modern technology standard.

About us

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 antibody-drug conjugates (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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Über das Unternehmen

Tubulis