Jobs in Germany
Regionalverband Saarbrücken
Overview
We are currently seeking a Senior Manager Clinical Quality Assurance* to strengthen our Clinical Quality Assurance (CQA) department. You will work remote (Germany) in an interdisciplinary environment with colleagues from Germany and the US. 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:
- Support of the implementation and maintenance of clinical QA processes and systems
- Maintenance of the clinical eQMS component including the definition, generation, and interpretation of quality metrics and trending reporting
- 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
- CQA Quality Management counterpart for the operational clinical functions; provision of 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, vendor selection and oversight aspects as well as support for the related eQMS deliverables
- 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
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 function. Experience in clinical trial quality management as well as in-depth knowledge of GCP regulatory requirements is expected. You are comfortable working at a global level in a highly matrixed environment. We expect excellent interdisciplinary and intercultural communication skills in English and preferably German.
A high degree of initiative, analytical reasoning and strong problem solving skills are required. 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.