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

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Senior Manager for Software process in the Quality Assurance department is an integral part of a highly productive team overseeing SDLC activities at the FMI headquarters site with close collaboration with the Technology Engineering team. The Senior Manager is responsible for oversight and management of the Software processes, SWQA operations, and SW metrics This position interacts with many teams in FMI most notably technology, IT, and InfoSec. The role works closely across all levels of a highly motivated and collaborative organization to ensure quality and timely execution of SDLC and quality requirements, adhering to compliance and safety standards while ensuring a patient-focused mindset.

Key Responsibilities

• Direct, advocate, and contribute to software related processes.

• Serve as a consultant on all things SW process related, providing support to users of the processes.

• Serve as the operations manager for the Software Quality Assurance team.

• Act as a manager of quality professionals; ensure activities are completed in alignment with goals and ensure continuous development of personnel.

• Serve as liaison to IT on automated implementation of process forms.

• Direct programs which assure the proper identification, compilation, and reporting of SW metrics.

• Be a subject matter expert and strategist for audit-related questions on the subject of SDLC and beyond, including front room and back room support for FDA, Notified Body, or pharma partners.

• Ensure all activities are conducted in compliance with the FMI Quality Management System and international and national regulations, and are aligned with regulatory agency expectations.

• Manage the SW process compliance for IVDR, ISO 13485, and pertinent regulatory bodies.

• Suggest changes to existing processes and establish measures to improve efficiency of these processes.

• Guide the organization on strategy and implementation of continuous improvement of the quality system as it pertains to SW development, InfoSec, and IT.

• Provide training and mentorship to less experienced members of QA staff across the QA organization.

• Ensure the work climate/culture within Quality System exemplifies our Company's Values.

• Other duties as required.

Qualifications

Basic Qualifications

  • One of the following education or experience combinations:
  • Bachelor’s Degree and 10+ years of experience in SDLC or related quality role for the pharmaceutical, biotechnology, or diagnostic industries; OR,
  • Master’s Degree and 7+ years of experience; OR,
  • PhD degree and 5+ years of experience

• 4+ years of management experience

Preferred Qualifications

• Experience with IVD, or Medical Device product development and validation

• 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

• Demonstrated ability to lead, communicate, interact and influence effectively across functions

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

• Experience acting as subject matter expert during regulatory audits

  • Experience with Computer Systems Validation methods and standards
  • Thorough understanding of ICH and GCP guidelines, including data integrity

• Demonstrated capacity to work in a fast-paced environment with strong attention to detail

• Comprehensive knowledge of Good Manufacturing Practices

• Proficiency in Microsoft Office, Word, Excel, Smartsheets, and PowerPoint

• Excellent communication skills and proven ability to work effectively in a multidisciplinary team

• Highly organized with strong attention to detail

• Understanding of HIPAA/GDPR and importance of privacy of patient data

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

 

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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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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