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SVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareer

SVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid

Welcome to 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:

  • Providing leadership for a team of 3 to 5 direct reports , focusing on development and team building
  • Developing, maintaining and documenting the entirety of QM and Regulatory Affairs activities & being involved directly and indirectly in the diagnostic processes, that include:
    • Uphold certification and accreditation activities nationally as well as internationally (CAP/CLIA, Dakks, EN ISO 13485:2016, and ISO 15189:2012)
    • Declare compliance in accordance to applicable regulations and laws such as MDR, IVDR CFR 21 part 820
    • Performing, documenting, presenting  and tracking of internal audits and support external third party audits
    • Ensuring compliance with legal and corporate requirements
    • Establishing the error management system, complaint management and the CAPA management system
    • System owner of the Quality Management System in accordance to 13485:2016, and ISO 15189:2012
    • Directing of quality documents, SOP’s and assisting other departments in structuring their documents
    • Directing the implementation of QM relevant training and continuous education of involved employees & stakeholders

You have the following skills and qualifications:

  • University degree in Biotechnology, Biology, Chemistry, Engineering or equivalent.
  • At least 10 years professional experience in the field of Quality Management and Regulatory Affairs, ideally gathered in a laboratory operation field (biotechnology or medical diagnostic) or a medical device company.
  • 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 ISO15185, ISO13485
  • Knowledge of CAP and CLIA
  • Independent personality, strong communication and organizational skills combined with good team spirit
  • Fluent English communication skills, written and spoken
  • Open to relocation to Rostock or Hybrid option

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.
SVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareerSVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareerSVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareerSVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareerSVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareerSVP Quality Management & Regulatory Affairs (m/f/d) in Rostock or Hybrid - Job Rostock, Home office - CentoCareer
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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

Anja Seidel
0381 80113 654