Manager QA GCP​/GLP

Manager QA GCP/GLP
About Tubulis

At Tubulis
, we are shaping a new generation of antibody-drug conjugates (ADCs) designed to bring safer, more effective treatments to patients with cancer. By combining proprietary conjugation technologies with deep expertise in biologics, we create targeted therapeutics that unlock the full potential of ADCs.

Join a passionate, multidisciplinary team committed to excellence, innovation, and improving patient outcomes worldwide.

We are seeking an experienced Manager QA GCP/GLP to join our Quality Assurance team. In this role, you will support the development of our innovative ADC pipeline and clinical programs, ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and all relevant regulations. Working closely with internal stakeholders and external partners, you will drive quality standards across research, development, and clinical activities.

• Design and maintain a global GCP audit program in collaboration with the Director, QA–GCP.

• Manage vendor qualification programs for assigned suppliers and service providers.

• Plan, execute, and deliver audits in the GCP area (all clinical phases, suppliers, systems, and documentation) to assess compliance with Tubulis SOPs and international regulations (ICH, CTR, FDA, EMA, national).

• Oversee audit activities for GLP vendors and review/approve GLP quality documentation provided by suppliers.

• Act as a subject matter expert, offering GxP guidance and interpreting regulations to identify risks, trends, and improvement opportunities.

• Represent QA in internal forums, including Tubulis trial team meetings, as assigned.

• Act as the QA counterpart for GCP/GLP vendors, addressing and resolving quality-related issues.

• Support regulatory inspections (preparation, hosting, and follow‑up).

• Contribute to the development and maintenance of the Quality Management System (QMS) for GCP/GLP in collaboration with the Director, QA–GCP.

• Bachelor’s or Master’s degree in a Life Sciences or Medical discipline.

• Minimum 5 years’ experience in Quality Assurance for GCP within the biotech or pharmaceutical industry.

• Proven experience auditing GCP vendors, including CROs, laboratories, and clinical trial sites.

• Experience auditing or overseeing audits of GLP vendors is an advantage.

• Fluent English (written and spoken).

• Strong knowledge of international GCP and GLP regulations and guidelines (EU, MHRA, FDA), or a willingness to develop GLP expertise.

• Excellent communication, problem‑solving, and stakeholder management skills.

• Flat hierarchies and quick decision‑making in an open, collaborative culture.

• Flexible working options, including mobile working.

• Unlimited contract after probation, with 30 days’ vacation.

• Competitive compensation and mobility allowance.

• A supportive, multicultural team with a strong sense of collegiality.

• Regular team events and a modern working environment.

Be part of our mission to deliver breakthrough ADC therapies to patients worldwide.