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QA Manager / QA Lead (m/f/d) - Limited to 24 month

  • Penzberg, Bavaria DE, Germany, 82377
  • Full Time

About the Job

The Manager, Quality Assurance is responsible for overseeing quality deliverables in area of assignment and expertise maintaining a competitive advantage for FMI. This position supports the execution of the planning and work of multiple projects with a big picture mindset and is accountable for achieving all related business goals.

Key Responsibilities

  • Perform and manage internal audits and external audits by regulatory authorities and pharmaceutical companies.
  • Perform external supplier and vendor audits (international and domestic).
  • Maintain current and accurate records of all relevant communications, audits, corrective action plans, and effectiveness monitoring.
  • Discuss audit and inspection findings with management staff to develop appropriate corrective and preventive actions where appropriate.
  • Generate and report required Quality Metrics and data for Management Review to meet regulatory requirements.
  • Subject matter expert and strategist for project-related questions within the subject matter area and beyond.
  • 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.
  • Formal training as auditor by a recognized organization.
  •  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 15189/13485/17025 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.
  • Track record in working in an international environment and fluency in spoken and written German and English.
  • Proficiency utilizing Microsoft Office Suite, specifically Excel and PowerPoint.
  • Excellent communication skills.
  • Familiarity with Laboratory Information Management System (LIMS).
  • Fluent in GERMAN and ENGLISH


Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form.  (EOE/AAP Employer)

To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.

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The past twelve months have been beyond exceptional and nobody can deny the impacts the global corona pandemic had on our daily lives. However, there were many positives. Our working environment had to quickly adapt to the new situation and employers and employees just the same had to accommodate to the new circumstances. Continued or exclusive work from remote has become “the new normal” – and to everyone’s surprise, it is working just as well. 

Learn more from Vera , VP, International Operations & Managing Director Foundation Medicine GmbH.


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. 

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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.

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