Person, Text, Face


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.


Sr Mgr, QA Design Assurance

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Sr Manager in the Quality Assurance department is a key and critical role at FMI. This role presents the incumbent with an opportunity to lead various teams within FMI. As a quality people manager you will be directing quality personnel working with Product Development Teams, laboratory operations teams, or quality systems programs. Overseeing quality deliverables in area of assignment and expertise while 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. When working with Product Development teams on new product and design changes projects, this role supports teams and project deadlines for submission of Bioanalytical plans and reports for Premarket Approvals and supplemental PMAs or IVDR Submissions. Additionally for Biopharma it supports clinical studies and collaborates with the partners on the clinical studies and Good Clinical Practices for the Diagnostic Device This position supports the planning and work of multiple project and scrum teams with a big picture mindset, and is accountable for achieving all related business goals. 

Key Responsibilities

  • Lead teams participating in the development and approval for design and development documents, quality system procedures, and laboratory documentation and controls. 
  • Subject matter expert and strategist for audit-related questions within their subject matter area and beyond including front room and back room support and management for FDA, Notified Body, or pharma partners.
  • Ensure all activities are conducted in compliance with the FMI Quality Management System, appropriate regulations, international and national regulations and are aligned with regulatory agency expectations.
  • Effectively collaborate with a fully integrated team to facilitate the completion of documents.
  • Maintain Quality Management Systems for functional area including Design Controls, Software Development, Risk Management, Corrective and Preventative Action (CAPA) system and Non-Conforming Material Reports.
  • Conduct root cause analysis and implementation of correction, corrective and preventative actions and verification of effectiveness of actions as periodically required in the identification and resolution of issues.
  • Guide the organization on strategy and implementation of continuous improvement of the quality system.
  • Management of quality professionals including ensuring activities are completed in alignment with goals and continuous development of personnel. 
  • Other duties as required.


Basic Qualifications

  • 2 years of management experience
  • Bachelor’s Degree in sciences or engineering discipline
  • 6+ years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry. 

Preferred Qualifications

  • 5+ years of management experience 
  • 8+ years of experience in medical device, diagnostics, clinical laboratory or biopharmaceutical industry 
  • Advanced Degree in the Sciences, Engineering or Business or a related field
  • Experience with next generation sequencing methodology
  • Evidence of knowledge of molecular biology
  • Experience with IVD, or Medical Device product development, analytical validation and product approval
  • Evidence of practical knowledge of standards and regulations pertaining to the medical device industry, both domestic and international, in particular standards set forth by the International Electrotechnical Commission and International Organization for Standardization
  • Demonstrate ability to lead, communicate, interact and influence effectively at technical levels across functions
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Deep knowledge of bioanalytical assay development, qualification, and validation requirements that comply with current regulatory standards
  • Proficiency in relevant analytical methodology and emerging new technologies
  • Strong skills in troubleshooting and problem solving
  • Comprehensive knowledge of Good Manufacturing Practices, Design Controls, Risk Management, Good Clinical Practices and Good Documentation Practices
  • Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Working knowledge of Next Generation Sequencing
  • 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.

Apply Now

Internal applicants, please use your FMI email address.

Please let me know about more jobs like this

Not You?

Thank you

Recommended Jobs

Sr. Manager, Medical Science Liaison - West

Medical Affairs 102594 San Diego California United States Torreyana Road, San Diego, California, United States Medical Full Time
About the Job The Senior Manager, Medical Science Liaison develops and expands a strong network of Key Opinion Leaders (KOLs) to support FMI’s commercial and scientific objectives. The position is responsible for initiating and sustaining an exch...

Customer Experience Specialist - West Coast (California, Nevada, Arizona, Washington)

Client Services 102584 California United States California, United States Client Services Full Time
About the Job The Customer Experience Specialist (CES) within the Customer Experience team partners directly with the FMI CEE team in support of key FMI accounts through insight into case management, escalations and specialized projects. This pos...

Customer Experience Executive (SC, Charlotte NC )

Client Services 102583 South Carolina United States South Carolina, United States Client Services Full Time
About the Job The Customer Experience Executive (CEE) within the Customer Experience team partners directly with a subset of current, key FMI accounts serving as a single point and liaison of contact for pre-, peri-, and post-testing. The positio...

Account Executive II - Eastern, Pennsylvania

Sales 102585 United States United States Commercial Full Time
About the Job The Account Executive II (AE II) is a field-based role with direct customer engagement on the Sales team within FMI’s Commercial operation. The position is responsible for driving sales volume for FMI’s suite of specialty products a...
Person, Clinic, Clothing, Lab Coat, Coat, Hospital, Operating Theatre, Sunglasses, Lab, People

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.