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.

 

Senior Manager, Software Quality Assurance

  • Second Street, Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Manager, Software Quality Assurance is responsible for planning, directing, and implementing programs supporting software development and software validation activities. This position uses strong software regulatory knowledge to deliver results on schedule in a fast-paced and dynamic environment.

Regular onsite work at a designated FMI location is an essential function of this role.

Key Responsibilities

• Manage SWQA team that is charged with validation support for SW applications.

• Build partnerships with SW development teams and leadership.

• Work with SW technology leadership on planning and scheduling QA support to execute on SW quality assurance commitments.

• Provide direction and guidance on SDLC process improvements.

• Provide Development teams with SW architecture guidance as it pertains to compliance requirements.

• Interpret requirements from regulatory domains including FDA, EU IVDR, PMDA, NYS, CLIA, CAP, etc.

• Provide expertise on medical device requirements management, software development, risk management, cybersecurity, and Verification and Validation.

• Ensure application of software best practices throughout the FMI Software Development Lifecycle.

• Participate in design reviews, requirements reviews, and process reviews.

• Lead RCA and Value stream analysis activities.

• Support internal and external audits of SW applications.

• Provide subject matter expertise and guidance to SW development teams on compliance matters.

• Lead and/or provide expert assistance on reporting, management, and resolution of SW related deviations, CAPAs, and audit findings.

• Guide the generation and reporting of Metrics related to SW quality, SW compliance, and validation efficiency.

• Travel up to 10% of the time.

• Other duties as assigned.

Qualifications

Basic Qualifications

• One of the following education or experience combinations:

  • Bachelor’s Degree and 10+ years of experience in SW development or SW test for the pharmaceutical, biotechnology, or diagnostic industries; OR,
  • Master’s Degree and 7+ years of experience; OR,
  • PhD degree and 5+ years of experience

• 5+ years of prior experience with quality systems and/or SW quality for medical device or healthcare software development

• 2+ years of prior experience with Agile SW development practices

Preferred Qualifications

• Experience with managing QA activities across multiple quality system requirements including FDA 21CFR Part 11/annex 11, Part 820, Part 812, part 814, EU IVDR, ISO 15189, ISO 13485, and CLIA/CAP

• Direct experience working with Regulatory, QA and software development teams

• Experience or familiarity with Companion Diagnostics

• Experience acting as subject matter expert during regulatory audits

• Experience with Computer Systems Validation methods and standards

• Demonstrated expertise in application of IEC 62304, ISO 14971, ISO 80001-1

• Scientific background in molecular biology and/or NGS

• Thorough understanding of ICH and GCP guidelines, including data integrity

• Ability to effectively interface with internal and external teams

• Ability to work in an environment that can change quickly and may be loosely structured at times

• Ability to match resources to tasks assess new challenges and prioritize accordingly

• Detail-oriented with excellent organizational skills

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.

 

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)

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