Quality Assurance Manager Foundation Medicine Germany (m/f)

Vollzeit | Penzberg, BAYERN | 5 Monate
Diese Position ist möglicherweise abgelaufen!

Jobübersicht

Vollzeit
Penzberg
Roche

Arbeitsbeschreibung


In 2015, Roche and Cambridge, MA-based Foundation Medicine announced a broad, strategic collaboration in the field of molecular information for oncology. The collaboration is a multi-part agreement that includes an R&D collaboration, an U.S. educational support collaboration, and an ex-U.S. commercial collaboration, among other aspects. Roche also invested $250 million into Foundation Medicine and, as part of a stock purchase, became a majority shareholder in Foundation Medicine. We believe this strategic collaboration accelerates and strengthens our respective leadership positions delivering molecular information solutions globally and advancing precision medicine in oncology. As part of the commercial collaboration, Foundation Medicine is building and plans to operate a molecular information, next generation sequencing facility in Penzberg, Germany. This laboratory will serve as Foundation Medicine’s strategic hub for commercial growth in several countries in Europe.
 
Foundation Medicine is leading a transformation in cancer care, where each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease. As a molecular information company, we are focused on fundamentally changing the way in which patients with cancer are treated. Our products provide more than information. They offer hope to patients, their families and friends, their physicians and caregivers. 
 
As a member of the Foundation Medicine team in Penzberg, Germany, you’ll work with everyone fighting the disease, patients and their families, payers, physicians, drug developers—to raise awareness about this transformation in cancer care and Foundation Medicine’s role to ensure we’re delivering the tools and information they need to make an impact and drive access for patients everywhere. Foundation Medicine is headquartered in the heart of Cambridge/MA, USA with a global office/laboratory in Penzberg, Germany.
 
Foundation Medicine is seeking to add a Quality Assurance Manager (m/f) to its rapidly growing team in Penzberg, Germany. This position will support QA activities at our newly established laboratory serving the European market to ensure compliance with ISO standards and applicable regulations and requirements. Main responsibilities cover:
  • Maintenance and continual improvement of an ISO 15189 and 13485 compliant Quality Management System
  • Partner with Lab Operations and support groups for proper management of nonconformities and in-depth root cause analysis
  • Manage Change Control processes
  • Provide review and feedback on validation plans and reports
  • Support accreditation activities
  • Prepare and support external audits by regulatory authorities and pharmaceutical companies
  • Oversee CAPA processes originating from internal/external quality audits or other sources
  • Ensure batch records are reviewed
  • Ensure that record keeping under Good Documentation Practices requirements are attributable, legible, contemporaneous, original and above all, accurate
  • Ensure that regulated equipment is properly maintained, cleaned and inspected on a routine basis per SOPs
  • Manage IQ/OQ activities of new equipment and oversee PM/calibration activities.
  • Responsible for ensuring that equipment standards are tested, calibrated and standardized before patient testing, and that all must be documented and approved.
  • Support creation and modification of equipment SOPs
  • Oversee Management of employee training files


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