Quality Manager (m/f/d) Early Clinical Trials
Working hours: full-time
Location: Biberach an der Riß
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 very well known pharmaceutical company. - Start: ASAP - Location: Greater Ulm area - Utilization: 100% - Until 30.09.2026 - The final job value is probably AT
Your tasks
* 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 as well as 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 (e.g. biology, pharmacy, chemistry), pharmaceutical sciences/clinical research, health sciences/public health, quality management/regulatory affairs. Or a Master's degree in Clinical Trial Management, GCP or Quality Management in Healthcare
* Or equivalent qualification with relevant education/further training and many years of professional experience.
* Many years of experience in the field of 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
* Very good knowledge of the relevant international and national regulations, e.g. GCP, AMG, MPG, GCP-V, relevant guidelines (ICH, FDA, EMA)
* Experience in quality management and training of employees
* Fluent in written and spoken German and English
Your prospects
* Team spirit and diversity
* Work-life balance
* Attractive remuneration
* Social benefits
* Versatile further training opportunities
* Team and sporting events
* Global network
* Attractive employee referral program
Benefits may vary depending on position and location. An overview of our benefits can be found on our website under Careers and benefits.
Have we piqued your interest?
Then we should definitely get to know each other! Please send us your CV preferably via our online application platform or via the e-mail address below and we will get in touch with you.
About us
We combine our many years of experience as a personnel service provider with extensive expertise in IT professions. You will find a wide range of different jobs in this field in our job advertisements. Our recruiters know exactly how the industry is developing and will find the job that suits you best.
Contact us
Mr. Tilman Markowetz
Tilman.Markowetz@akkodis.com
Akkodis Germany Tech Experts GmbH
Life Science
Talstrasse 4
79102 Freiburg
Phone +49 761 38908 213
www.akkodis.com/de
Job-Identifikationsnummer: 00738886-1