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

Akkodis Germany Tech Experts GmbH; Burgos; Presencial; EUR 45.000 - 60.000; Jornada completa

Descripción de la vacante

Akkodis is seeking a Quality Manager for Early Clinical Trials to work with notable clients in the pharmaceutical sector. The role involves overseeing quality assurance processes, compliance with regulations, and supporting clinical operations. Ideal candidates will have a relevant degree and substantial experience in clinical trials, as well as fluency in both German and English.

Formación

• Degree in natural sciences (biology, pharmacy, chemistry) or equivalent qualification.
• Extensive experience in phase 1 clinical trials.
• Fluent in German and English.

Responsabilidades

• Organize preparation, implementation, and follow-up of audits and inspections.
• Create and manage controlled documents and templates.
• Initiate process improvement measures and CAPAs.

Conocimientos

Quality Management

Clinical Research

Regulatory Requirements

Team Spirit

Educación

Degree in Natural Sciences

Master's in Clinical Trial Management

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 our 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. From start-ups, family businesses, medium-sized companies to global big players, we have a wide variety of clients and requirements. We are looking for a Quality Manager (m / f / d) Early Clinical Trials for a well-known pharmaceutical company. - Start : ASAP - Location : Greater Ulm area - Utilization : 100% - Until 30.09.2026

Responsibilities

• Organization / support in the preparation, implementation, and follow-up of inspections, internal and external audits, and assessments.
• Timely creation of action plans and their follow-up in close cooperation with Quality Medicine Germany.
• Support and responsibility for the creation and management of controlled documents and templates for processes, including checking for relevance to functions and comparison with SOP distribution lists and familiarization lists (maintenance of specific curricula).
• Independent implementation of quality controls, e.g., check of relevant audit procedures and documentation (source data, CRFs, ICs, internal process descriptions, etc.).
• Initiation of process improvement measures and CAPAs.
• Support the team by providing advice and assistance on issues related to quality, processes, SOPs, improvement activities, and data protection.

Your profile

• Degree with several years of relevant experience, e.g., a degree in natural sciences (biology, pharmacy, chemistry), pharmaceutical sciences / clinical research, health sciences / public health, quality management / regulatory affairs, or a Master's in Clinical Trial Management, GCP, or Quality Management in Healthcare.
• Or equivalent qualification with relevant education / further training and many years of professional experience.
• Extensive experience in phase 1 clinical trials (e.g., as a Study Nurse, Clinical Research Associate, GCP Auditor).
• Very good understanding of clinical research, quality management, and regulatory requirements.
• Excellent knowledge of relevant international and national regulations, e.g., GCP, AMG, MPG, GCP-V, guidelines (ICH, FDA, EMA).
• Experience in quality management and employee training.
• Fluent in written and spoken German and English.
• Team spirit and appreciation of diversity.

Benefits may vary depending on position and location. An overview of our benefits can be found on our website under Careers and benefits.

If you're interested, please send us your CV via our online application platform or email, and we will get in touch.

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.

J-18808-Ljbffr