Quality Manager (m/f/d)
Welcome to CENTOGENE!
CENTOGENE’s mission is to provide data-driven, life-changing answers to patients, physicians, and pharma companies for rare and neurodegenerative diseases. We integrate multiomic technologies with the CENTOGENE Biodatabank – providing dimensional analysis to guide the next generation of precision medicine. Our unique approach enables rapid and reliable diagnosis for patients, supports a more precise physician understanding of disease states, and accelerates and de-risks targeted pharma drug discovery, development, and commercialization.
How do we do this? By bringing together more than 400 individuals from 50 different countries at our HQ in Rostock, Germany, as well as our offices in Berlin, Belgrade, and in Cambridge, MA. Our employees are medical experts, scientists, IT professionals, bioinformaticians, technicians, researchers, project managers, and many more – and are all passionate about supporting our company vision : A world healed of all rare and neurodegenerative diseases.
Does this sound like you? If it does, we’d love to hear from you!
Your tasks and responsibilities:
- Support continuous improvement of the Quality Management System to ensure current regulatory requirements
- Preparation and implementation of internal policies and SOPs
- Handling of change control requests, non-conformities, SCARs and CAPAs
- Conducting risk management (ISO14971) and root cause analysis
- Monitoring of instrument qualification and calibration
- Participate in internal and supplier audits
- Support governmental and partner audit readiness
You have the following skills and qualifications:
- A master degree in Biology, Chemistry, or related field, or equivalent background
- Minimum of 3 years as Quality Management Representative, or other quality area
- Practical expertise within regulated industry preferred (CAP, CLIA, ISO15189, ISO 13485, FDA 21 CFR 820 and/or similar)
- Experience with electronic document management systems favored
- Practical skills in internal/external audits preferred
- Proof of experience in Microsoft Office applications
- Highly proficient in spoken and written English
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 relocation support 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.
Scope of activities
Process planning and quality assuranceCareer level
ProfessionalLocation
Am Strande 7, 18055 Rostock, GermanyEmployment type
Full timeFor 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.
