Director Quality Management (m/f/d) - Job Rostock - CentoCareer

Director Quality Management (m/f/d)

Start your career at CENTOGENE

We 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 350 individuals from 45 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:

As the Director of Quality Management you are ultimately responsible for all of CENTOGENE’s QM activities, while working closely with the involved departments and stakeholders. As we continue to grow internationally the focus on our processes and compliance stays continuously strong and establishes CENTOGENE as a trusted partner throughout the industry.
 

  • Providing leadership for a growing team of currently 4 members, focusing on development and performance
  • Developing, maintaining and documenting the entirety of QM activities & being involved in the QM of all diagnostic processe, that include:
    • Planning and organization of all laboratory audits
    • Performing, documenting and tracking of internal audits
    • Continuous monitoring of all QM relevant internal parameters
    • Investigating the error management system, complaint management and implementation of the CAPA processes
    • Preparation of quality documents to improve processes
    • Creation of quality documents and assisting other departments in structuring their documents
    • Implementation of QM relevant training and continuous education of involved employees & stakeholders
    • Reporting for all critical QM related activities directly to the CEO
    • Continuous improvement of all aspects of GLP, GMP, ISO15185, ISO13485, ISO9001 in the laboratory

You have the following skills and qualifications:

  • University degree in Biotechnology, Biology, Chemistry or Medicine
  • Sound professional experience in Quality Management, ideally gathered in a laboratory operation (biotechnology or medical diagnostic)
  • Well-experienced in team leading & team building
  • Familiar with working in an international organization and a multicultural environment 
  • Safe and senior handling of international QM systems (implementation, development, auditing) and related processing of external accreditations as Compliance Manager
  • Knowledge of GLP, GMP, ISO15185, ISO13485, ISO9001
  • Knowledge of CAP and CLIA
  • Independent personality, strong communication and organizational skills combined with good team spirit
  • Fluent English communication skills

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
 

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