We are currently seeking a Senior Director Clinical Quality Assurance* to strengthen our CQA department. You will work in Tübingen, Munich or remote (Germany) in an interdisciplinary environment with colleagues from Germany and the US (Houston, TX). Your analytical reasoning and action-oriented style as well as your organization and communication skills will contribute to the global team’s success.
Your main responsibilities will include but are not limited to the following tasks:
- Head the CQA department
- Plan, implement and constantly improve Immatics´ Clinical Quality Assurance across all involved business areas
- Supervise line reports and contracted external staff, develop budgets and monitor expenditures for CQA functions
- Plan and implement the GCP audit program (internal and external)
- Support preparation for GCP related regulatory inspections and third party audits
- Report Quality KPIs within CQA
- Coordinate the GCP vendor qualification
- Work closely with the Quality Management Systems department to provide guidance and support for the harmonization and continuous improvement of GCP compliant QMS across sites
You hold a University degree in natural sciences/ engineering/ quality management. You have gained 10+ years of experience in working or consulting for mid-size life sciences companies in Clinical Quality Assurance, ideally in an early-stage and as well as late-stage clinical development environment. You gained leadership experience in the execution of QMS in a GCP regulated environment. You are well versed in GCP requirements for drug development (ICH-E6(R2)) and industry QM standards (ISO 9000 series). Good understanding of GMP and GLP requirements is a plus. You are experienced in the interaction with regulatory agencies overseeing GCP compliance (e.g., FDA, PEI) and comfortable in working at a global level in a highly matrixed environment. You have proven ability to innovate across business processes and to implement solutions leading cross-functional teams. We expect excellent change management skills and interdisciplinary and cross-cultural communication in English, German is a plus.
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.
*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.
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.