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
Create and maintain global GCP audit programs in collaboration with the Director QA-GCP.
Manage the vendor qualification program of assigned vendors.
Manage (planning, execution, and delivery) and / or oversee audit activities in the GCP area for all phases of clinical studies, suppliers, systems, and documents to assess compliance with Tubulis SOPs and applicable regulations and guidelines (e.g. ICH, CTR, US FDA, and National regulations), identifying compliance issues, communicating results to and educating auditees, project teams, and management.
Manage audit activities (planning, execution, and delivery) for GLP vendors and review and approve GLP quality documentation provided by vendor.
As subject matter expert provide GxP expertise (interpretation and guidance), in collaboration with relevant internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities and provide input for mitigation activities.
Represent QA in internal meetings, e.g. in Tubulis Trial Team meetings, as assigned.
Act as QA counterpart to GCP / GLP vendors to address and resolve any quality issues.
Support regulatory inspections (preparation, hosting, follow-up), as requested.
Support Director QA GCP in development and maintenance of quality management systems (QMS) in the area of GCP / GLP.
Your profile
BS/MS in Life Science field or medical field.
At least 5 years of experience of QA GCP in biotech.
Experience in auditing GCP vendors including full service CROs, laboratories and clinical trial sites.
Experience in auditing and/or overseeing audits of GLP vendors.
English fluent, written and spoken.
Very good knowledge of international GCP and GLP regulations and guidance (EU, MHRA, and FDA regulations), or willingness to get into GLP QA area.
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.
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.
#J-18808-Ljbffr