Senior Manager Clinical QA - Auditing Focus*

Immatics Biotechnologies GmbH; München; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading biotechnology company is seeking a Senior Manager Clinical QA with an auditing focus. This full-time role in Munich or Tübingen involves conducting audits, reviewing quality documents, and ensuring compliance with regulations. The ideal candidate holds a university degree in natural sciences and has over 5 years of relevant experience. Excellent communication skills in English and preferably German are required, along with the ability to work in a global environment. Join a committed team focused on improving cancer patient outcomes.

Leistungen

Job bike

Job ticket

Health Programs

Childcare benefits

Relocation allowance

Company summer and winter events

Qualifikationen

• 5+ years of experience in life sciences companies.
• Experience in general audit execution and investigator site auditing.
• Operational clinical trial management experience is considered an advantage.

Aufgaben

• Conduct internal and external audits.
• Review and approve quality-related documents.
• Support implementation of inspection readiness concepts.
• Conduct quality-related trainings for colleagues.
• Provide quality guidance to clinical functions.

Kenntnisse

Experience in clinical quality management

Knowledge of ICH-GCP/GCLP regulatory requirements

Strong analytical skills

Problem-solving skills

Excellent communication skills in English

Intercultural communication skills

Ausbildung

University degree in natural sciences or related field

Jobbeschreibung

Senior Manager Clinical QA - Auditing Focus\* page is loaded## Senior Manager Clinical QA - Auditing Focus\*locations: Tuebingen (Germany): Munich: Remote Work (Germany)time type: Full timeposted on: Posted 4 Days Agojob requisition id: JR100525**OVERVIEW**We are currently seeking an experienced full- or part-time (mind. 32 hrs/ week) Senior Manager Clinical QA - Auditing Focus\* 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:* Conduct of internal and external audits (investigator site audits and vendor audits)* 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 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 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 general audit execution and, specifically, investigator site auditing is required. A background in quality management within a clinical trial environment and strong knowledge of ICH-GCP/ GCLP regulatory requirements are expected. Operational clinical trial management experience is considered an advantage.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.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.Immatics’ fundamental purpose is to apply its technology and drug development efforts toward improving the outcomes for cancer patients through the exciting advances of using the immune system to fight the disease.From its research and development origins in Tübingen, Germany, to its cell therapy center in Houston, Texas and corporate functions in Munich, Germany, Immatics represents a trans-Atlantic team united to build a global leader in T cell receptor-based immunotherapies.We are only accepting digital applications via the application form of each position. For general inquiries on recruiting topics, please write a message to [e-mail] for German recruiting topics or [e-mail] for US recruiting topics.