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Every patient sample is a story.

That's why our Lab Ops team is focused on providing physicians with comprehensive genomic information about each person's cancer. Information that's as unique as the patients are. The insights discovered in our labs may help change their story.


Quality Assurance Training Manager

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Quality Assurance Training Manager 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

  • Oversee the overall GxP training program to provide a robust, compliant, streamlined training program that supports GXP operations and can withstand the rigor of regulatory inspections.
  • Manage the day-to-day activities in the electronic training management system (Cornerstone).
  • Maintain GxP training records and files.
  • Partner with functional departments to create and maintain the training matrix for all.
  • Instruct and administer Quality Systems classroom training when needed/onboarding.
  • Participate in Inspection readiness activities to ensure the training program is continuously inspection ready.
  • Support biopharma audit and inspection activities by being the training subject matter expert. Act as subject matter expert for audit-related questions within subject matter area and beyond, including front room and back room support and management for CAP, CLIA, FDA, Notified Body, or pharma partners.
  • Participate in internal audits as needed.
  • Provide training metrics to monitor the health and effectiveness of the training program.
  • Participate in Quality Management Meetings representing training program performance.
  • Develop effective cross-functional relationships with functional areas within FMI sustaining engineering and site management to meet departmental and organizational goals.
  • Serve as engaging collaborator by building and maintaining strong relationships within FMI and serve as a liaison between functional departments and Quality.
  • Track Quality Performance Metrics and participate in monthly quality reviews.
  • Ensure regulatory requirements related business processes are implemented and maintain compliance.
  • Support investigation activities for the determination of root causes of product and performance deviations (e.g. CAPAs and NCR).
  • Act as a liaison with other functions to capture and analyze any requested changes against the product and regulatory requirements.
  • Serve as technical reviewer for projects and programs across the FMI organization.
  • Ability to travel up to 10% of the time.
  • Other duties as assigned.


Basic Qualifications

  • Bachelor’s degree in science or engineering discipline with 5 years’ experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry OR 
  • Master’s degree with 3 years’ experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry

Preferred Qualifications

  • Demonstrated ability to work in a team environment effectively
  • Demonstrated ability to effectively interface with internal and external teams
  • Self-motivated, with a strong attention to detail and the ability to multitask
  • Excellent written and oral communication with exceptional organizational skills
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion


About Foundation Medicine

Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.

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Internal applicants, please use your FMI email address.

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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.