Job in Germany : Quality Manager (m / w / d) Early Clinical Trials

Akkodis Germany Tech Experts GmbH; Torrejón de Ardoz; Presencial; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

Akkodis is seeking a Quality Manager for Early Clinical Trials to work with a renowned pharmaceutical company. The role involves organizing inspections, developing documents, and ensuring compliance with regulatory requirements. Ideal candidates will have a degree in a relevant field and significant experience in clinical trials, along with fluency in German and English.

Formación

• Significant experience in phase 1 clinical trials (e.g., as Study Nurse, CRA, or GCP Auditor).
• Strong understanding of quality management and regulatory requirements.
• Excellent knowledge of GCP, AMG, MPG, GCP-V, ICH, FDA, EMA.

Responsabilidades

• Organize and support inspections, audits, and assessments.
• Develop and manage controlled documents ensuring compliance.
• Perform quality controls and initiate process improvements.

Conocimientos

Quality Management

Clinical Research

Regulatory Requirements

Team-oriented

Fluency in German

Fluency in English

Educación

Degree in natural sciences, pharmaceutical sciences, or related field

Descripción del empleo

Quality Manager (m / f / d) Early Clinical Trials

Working hours: Full-time

Akkodis, formed through the merger of AKKA & Modis, is a global leader in engineering & IT. As a global partner in an ever-changing technology & competitive environment, we support our customers with a comprehensive 360° offering to create a more sustainable & smarter future. United by our shared passion for technology & talent, we look at the world from a new perspective. Our 50,000 motivated engineers & digital experts go beyond the possible every day to create the incredible.

At Akkodis Life Sciences, we staff projects throughout Germany for renowned clients in the pharmaceutical, biotech, and chemical industries. We work with a wide variety of clients, from start-ups and family businesses to medium-sized companies and global corporations. We are seeking a Quality Manager (m / f / d) for Early Clinical Trials for a well-known pharmaceutical company.

Details:

• Start: ASAP
• Location: Greater Ulm area
• Utilization: 100%
• Contract Duration: Until 30.09.2026

Responsibilities

1. Organize, support, and follow up on inspections, internal and external audits, and assessments.
2. Create and monitor action plans in collaboration with Quality Medicine Germany.
3. Develop and manage controlled documents and templates for processes, ensuring relevance and compliance with SOPs and curricula.
4. Perform quality controls, including audits of relevant documentation such as source data, CRFs, ICs, and process descriptions.
5. Initiate process improvements and CAPAs.
6. Advise and assist the team on quality issues, processes, SOPs, and data protection.

Your profile

1. Degree in natural sciences, pharmaceutical sciences, health sciences, quality management, or a related field, with relevant experience, or equivalent qualification with extensive training and experience.
2. Significant experience in phase 1 clinical trials (e.g., as Study Nurse, CRA, or GCP Auditor).
3. Strong understanding of clinical research, quality management, and regulatory requirements.
4. Excellent knowledge of international and national regulations (GCP, AMG, MPG, GCP-V, ICH, FDA, EMA).
5. Experience in quality management and training.
6. Fluent in German and English, both written and spoken.
7. Team-oriented with an appreciation for diversity.

Benefits may vary depending on the position and location. Please visit our website under Careers and Benefits for an overview.

If interested, please submit your CV via our online platform or email us, and we will contact you.

About us

We combine extensive experience as a personnel service provider with expertise in IT professions. Our wide range of jobs in this field is available in our job advertisements. Our recruiters understand industry developments and will help find the best job for you.