Senior Manager Clinical Quality Assurance*
immatics biotechnologies
OVERVIEW
We are currently seeking a Senior Manager Clinical Quality Assurance* to strengthen our Clinical Quality Assurance (CQA) department. You will either work in one of our office locations in Tübingen or Munich, or remote (Germany) in an interdisciplinary environment with colleagues from Germany and the US and will contribute to our mission of delivering novel PRAME immunotherapies to patients with cancer.
YOUR MISSION
Your main responsibilities will include but are not limited to the following tasks:
Support of the implementation and maintenance of clinical QA processes and systems
Creation or review and approval of quality related documents, including, e.g., QMS SOPs, working instructions, and respective quality documentation related to clinical trial management activities
Support of the vendor selection, qualification and outsourcing management process
Conduct of internal and external audits (vendor and investigator site audits)
Support of the implementation and the maintenance of inspection readiness concepts and the preparation, hosting, and follow up of regulatory inspections
Organization and conduct of quality related trainings to colleagues
Provision of quality guidance and support to clinical functions for, e.g., protocol and process deviation management, change controls, root cause analyses, CAPA definitions for deviations/ audits and inspection observations as well as support for the related (e)QMS deliverables
Support of the maintenance of the clinical (e)QMS including the definition, generation, and interpretation of quality metrics and trending reporting
YOUR PROFILE
You hold a University degree in natural sciences, engineering, quality management, or a related field, and have gained 5+ years of experience in working for life sciences companies in a clinical quality management/ assurance function. Experience in clinical trial quality management and auditing as well as in-depth knowledge of GCP regulatory requirements is expected. You are comfortable working in a global and matrixed business environment. Excellent interdisciplinary and intercultural communication skills in English and preferably German complete your profile.
We expect a high degree of initiative, analytical reasoning and strong problem solving skills. 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 the global leader in precision targeting of PRAME. Driven by our mission to make an impact on the lives of patients with cancer, 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.