About the Job
This position will expand and strengthen the FMI Germany team in Penzberg, which currently consists of approx. 50 employees from various functions. Our mission is the preparation, sequencing and analysis of tissue and blood samples from cancer patients to produce a report that supports the personalized treatment of the patient. The start-up mentality and a high degree of team spirit distinguish us from other companies in the field, which is reflected in fast decision making, mutual support and a high degree of trust. For over three years now we have been making a real contribution to the lives of many patients worldwide. In order to continue to do this successfully, we are seeking to add a Manager, Quality Assurance, to our rapidly growing team in Penzberg, Germany.
· Ensure GCP/GCLP compliant quality processes for clinical studies supported or sponsored form Foundation Medicine.
· Surveillance of reference laboratories and critical subcontractors.
· Complaint and SAE/AE reporting.
· Provide review and feedback on validation plans and reports.
· Support accreditation activities.
· Prepare and support internal audits and external audits by regulatory authorities and pharmaceutical companies.
· Ensure that record keeping under Good Documentation Practices requirements are attributable, legible, contemporaneous, original and above all, accurate.
· Maintenance, surveillance and continual improvement of an ISO 15189 and 13485 compliant Quality Management System (QMS).
· Complete training on additional Foundation Medicine QMS elements to act as competent back-up
· Scientific Academic degree or similar.
· Multi-year working experience in a relating field; preferably in the regulated pharmaceutical, biotechnology or diagnostic industries.
· Strong regulatory compliance knowledge including applicable GCP, ISO standards, as well as CLIA, CAP and FDA QSR knowledge.
· Scientific background in molecular biology and/or NGS
· Experience with managing QA activities across multiple quality system requirements (e.g. operating under both ISO 15189/13485 standard and FDA part 820 regulations).
· Able to communicate professionally across a variety of stakeholders to support internal and external audits of commercial partners or suppliers.
· Must be detail oriented with excellent prioritization and organizational skills.
· Superior analytical and problem-solving skills.
· Must be able to provide results on schedule in a fast-paced, dynamic environment.
· Business acumen to balance highest quality standards with timely delivery of results to patients.
· Track record in working in an international environment and fluency in spoken and written English.
· Proficiency utilizing Microsoft Office Suite, specifically Excel and PowerPoint.
· Well organized.
· Excellent communication skills.
· Familiarity with Laboratory Information Management System (LIMS).
Internal applicants, please use your FMI email address.
Foundation Medicines European subsidiary is located within the Roche Campus in Penzberg, Germany, just a couple of miles south of Munich. Roche Penzberg is one of Europe’s largest biotechnology centers, employing around 6,200 people from over 50 nations.
In addition to laboratory operations, the site functions as hub for internal collaborations and partnerships. The central location in Europe and within the Penzberg campus allow for a strong synergy between Foundation Medicine, various national and international partners and Roche.
The Foundation Medicine team in Penzberg consists of several groups, such as Laboratory Operations, Client Services & Accessioning, Computational Biology, Quality Assurance, Automation Engineering, Project management, Finance and IT. Many of the Roche amenities on campus can also be used by Foundation Medicine employees, such as the gym, canteen, and bus services.
Learn more about our German location from our Project Manager, Barbara.