Quality Manager / Quality Assurance Manager (m/f/x) (IMGM Laboratories)
The Precision Medicine business unit is focusing on biomarker early stage and clinical development and commercialization programs of companion diagnostics in oncology and rare diseases and expanding into applied markets. With our wide network of more than 100 large clinical laboratories in Europe we are turning rapid, turnkey in-house testing for decentralized community hospitals and precision diagnostics into a reality.
Medicover Integrated Clinical Services (MICS) is a specialised business unit within the Diagnostic Services division with more than 200 employees that is focusing on clinical trial and patient management that are relevant for applications and clients from pharmaceuticals, diagnostics biopharma, biotech, contract research organisations (CROs), biobanks, and other players within this clinical sector. MICS has been providing bespoke services to our clients and their patients for over 20 years, making strategic use of Medicover assets, including laboratories with state-of-the-art diagnostic equipment, medical clinics and hospitals.
We are a leading clinical research service provider guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services in precision medicine.
Join our company on an ongoing journey of shaping the way health care performs in the future.
This position will be located in Martinsried (near Munich) / Germany.
About the role
For our location IMGM Laboratories GmbH in Martinsried near Munich, we are looking for an experienced Quality Manager and Quality Assurance Manager to join our team specializing in DNA and RNA analysis. The candidate should have a strong molecular biology and genetics background, and be familiar with advanced technologies such as qPCR, ddPCR, and Next-Generation Sequencing. The role involves maintaining and developing our quality management system in accordance with GCP, GLP, and Iso17025 standards. We are looking for an analytical and thorough candidate with experience in quality management and quality assurance, who can work independently and as part of a team.
The priorities of the role:
- You are responsible for maintaining and further developing the implemented QM system according to DIN EN ISO/IEC 17025 and the GLP and GCP guidelines and, if necessary, adapting it to other relevant standards
- You ensure quality when conducting clinical studies (GCP) and non-clinical safety studies (GLP).
- You monitor the implementation of internal and external regulations
- You are responsible for internal and external audits and support for customer audits and official inspections
- You are responsible for releasing validation reports, processing CAPA and document control
- You manage change controls and risk management
- You train employees on QM-relevant topics
- You are the contact person for all employees with regard to the requirements of the regulations
- You have a scientific degree or training in the medical-technical field
- You have professional experience in the area of QM/QA (e.g. ISO, GxP, accredited area).
- You have applied knowledge in the field of molecular biology and/or pharmaceuticals and, if possible, in other medical analysis techniques
- Good understanding of regulations and quick familiarization with new subject areas
- Independent and responsible work, structured and precise working methods are a matter of course for you
- You communicate fluently in German, knowledge of English is an advantage
- You have the ability to motivate others and resolve conflicts constructively
Even if you don’t meet all the criteria, we look forward to receiving your application!
- We offer you an exciting and secure job with a responsible area of responsibility in a future-oriented company.
- You need vacation? With us you get 30 vacation days for your relaxation.
- An open and collegial team supports you in your tasks and is also happy to assist you beyond the induction phase.
- We give you the freedom to develop your own ideas and let you work independently and on your own responsibility.
- A friendly and respectful departmental and working atmosphere as well as an open communication culture ensure your feel-good factor.
- Extensive training opportunities promote your development and secure your long-term prospects in the company.
- We offer you discounts, e.g. on travel, fashion, electronics and much more via corporate benefits.
- Joint ventures and team events ensure good team spirit.
- If you are coming by public transport, the bus stop is right across the street.