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Quality & Compliance Manager for Clinical Studies (m/w/d) - Job Rostock - CentoCareer

Quality & Compliance Manager for Clinical Studies (m/w/d)

Welcome at CENTOGENE!

We, CENTOGENE GmbH ("CENTOGENE"), are the experts in rare hereditary diseases. We know the genetic basis and the clinical phenotype of genetic disorders inside-out. Our platform is based on the world’s largest curated mutation database for rare diseases. We have an unrivaled global diagnostic footprint, and an unmatched ability to derive diagnostic solutions to accurately identify rare disease patients and accelerate the path to approval for new orphan drugs.

How do we do this? By bringing together more than 500 individuals from 50 different countries to transform clinical and genetic data into medical solutions for patients. We work together at our HQ in Rostock, Germany, and also at additional offices in Berlin and laboratory facilities in Cambridge MA. Our employees - medical experts, scientists, IT professionals, bioinformaticians, technicians, researchers, project managers, and many more - are all passionate about one thing: improving the lives of our patients.

Does this sound like you? If it does, we’d love to hear from you.

Your tasks and responsibilities:

The Clinical Studies Quality & Compliance Manager ensures comprehensive and sensible quality management as well as overall compliance, in order to ultimately reinforces the validity of the collected data, thus strengthening the credibility of conducted non-interventional clinical studies.

  • Responsible for any quality and compliance topic related to the Clinical Studies Department
  • Supervising overall Clinical Studies Department’s quality and training compliance
  • Develop, establish, maintain, revise and adapt Clinical Studies Department related SOPs, processes, user manuals and work instructions to ensure systematic quality assurance
  • Support the communication and training of SOPs to operational teams
  • Provide day-to-day quality and regulatory advice to the Clinical Studies Department staff<!--[endif]-->
  • Develop and deliver training related to clinical studies within the department and across the company as required
  • Act as main interface with the corporate Quality Management Department allowing synchronization and streamlining of processes and systems
  • Planning and performing internal audits, generating respective audit reports, and diligently initiate, follow up and document CAPAs accordingly

You have the following skills and qualifications:

  • Scientific degree (or equivalent educational background) with at least 5 years’ experience in the field of quality assurance or management in clinical research, preferably in biotech or pharma companies
  • Experienced in establishing and writing SOPs, processes, user manuals and/or work instructions
  • Knowledge of clinical studies (ideally non-interventional) and related national and international regulatory requirements and guidelines including but not limited to ICH-GCP, FDA CFR 21 and EMA Guidelines, AMG
  • Strong communication and presentation skills (English and German) with the ability to build quick rapport with all levels of internal and external customers
  • Excellent organizational skill, combined with an analytical mindset and strong decision-making skills
  • Motivated team player with a high level of integrity and, the ability to prioritize and to work autonomously on multiple projects
  • Experienced in developing and delivering technical training to operational staff of advantage
  • Proficiency in standard MS Office applications; skills in using Microsoft Visio to develop process flowcharts would be beneficial

Those advantages are waiting for you at CENTOGENE:

  • Talents are individually supported by internal and external trainings
  • An international career in a multicultural environment
  • Regular company events form us as one team
  • In house yoga classes, back exercises and a fitness area are available for free
  • Lunch breaks and meetings on our roof terraces feel like vacation when looking at the Warnow
  • Bike leasing or job tickets allow an environmentally friendly and reasonable travel to work
  • In case of language barriers we offer German and English classes as well as support in finding accommodation to help you get going
  • Precaution and financial protection guaranteed by company pension scheme


Applications from severely disabled people with appropriate suitability are explicitly welcome. Severely disabled applicants and equivalent status are given preferential consideration in the event of equal qualification.
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For those who embark on a career with CENTOGENE, they’ll enjoy an exciting, dynamic, entrepreneurial and extremely fast-paced environment. Working alongside dedicated colleagues, CENTOGENE employees enjoy other benefits including upskilling from a dedicated training department, yoga classes, company-sponsored bicycle leasing, German language classes, and new state-of-the-art premises conveniently located featuring roof terraces and an in-house fitness center. For employees new to Rostock we’ll also support on finding local housing.

Who we are

CENTOGENE is a rare disease company focused on transforming clinical, genetic, and biochemical data into medical solutions for patients. We are focused on bringing rationality to treatment decisions and accelerating the development of new orphan drugs by using our knowledge of the global rare disease market, including its epidemiological and clinical heterogeneity and our innovative biomarkers.

As one of the largest rare disease companies worldwide, CENTOGENE is dedicated to transforming the science of genetic information into solutions and hope for patients with rare diseases and their families. 

Contact

Marica Keppler
+49 381 80113 668