SQA Engineer ensuring quality and reliability of software for 5G products. Collaborating with developers and performing test plans for performance, functionality, and robustness.
About the role
- QA Manager responsible for GCP and GLP audit programs at Tubulis, a biotech company focused on cancer treatment. Collaborate with teams to ensure compliance and quality in clinical trials.
Responsibilities
- 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).
- Identify compliance issues, communicate results to and educate auditees, project teams, and management.
- Manage audit activities for GLP vendors and review and approve GLP quality documentation provided by vendor.
- Provide GxP expertise in collaboration with relevant internal functions to identify, assess, and communicate quality related risks and trends and improvement opportunities.
Requirements
- 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.
Benefits
- 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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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