Overview
We are currently seeking a CQA Manager* (Clinical Quality Assurance Manager) to strengthen our global CQA/QMS department. You will work in Tübingen, Munich or Germany home-based in an interdisciplinary environment with colleagues from Germany and Houston (TX). Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the team’s success.
Your mission
Your main responsibilities will include but are not limited to the following tasks:
- Implement and maintain QA related to Immatics’ clinical trials (GCP QA function)
- Plan, conduct and follow-up internal audits of GCP relevant systems and processes
- Support preparation and hosting of regulatory inspections
- Provide support and maintain documentation and oversight of CQA related change controls, GCP and protocol deviations, related CAPAs, and SOPs
- Support the generation of annual audit schedules
- Organize and deliver GCP and quality related trainings for Company personnel
- If required,
- plan, conduct and follow-up clinical trial related audits, e.g., GCP vendor audits, trial site audits, and/ or document audits; or support these activities
- provide support to clinical functions regarding GCP vendor selection, qualification and oversight
- support the selection of external auditors
- support the budget estimation related to CQA audits
- act as deputy of CQA at Immatics US, regarding all above activities
Your profile
You hold a university degree in natural sciences, engineering, quality management, or a related field. You have 3+ years of experience in working or consulting for life sciences companies in Clinical Quality Assurance. You are well versed in GCP regulatory requirements. You are comfortable working in a highly matrixed global environment. Excellent interdisciplinary and intercultural communication skills in English are desirable, German is a plus. You have a high IT affinity and your motivation is driven by the passion for your work. You approach tasks in a structured, reliable and foresighted manner, combined with an elevated level of individual responsibility, enthusiasm and strong social skills.
Why us?
We are a committed and inspired team and cherish the collegial, highly motivated, and family-friendly atmosphere within Immatics. Our culture allows for a high level of originality, independent thinking, and initiative. We believe in supporting our employees’ professional and social skills: We enable them to join conferences and trainings as well as to enjoy our Immatics benefits – e.g., job bike, job ticket, Health Programs, childcare benefits, relocation allowance, Company summer and winter events.
Notice
*We value diversity and inclusion. Immatics N.V. and all Immatics subsidiaries are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.
About Us
Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets.
This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.
