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.

 

Supervisor, Right to Operate

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

About the Job

The Supervisor, Right to Operate, is responsible for leading a supporting team within Laboratory Operations in adhering to state, local and federal regulations, as well as internal policies and procedures. The Supervisor applies regulatory and quality system knowledge to fulfill the job responsibilities. This position shifts priorities based upon business needs and coordinates multiple projects concurrently. This role is considered an essential onsite role with the potential for flexible work from home options in emergency situations.

Key Responsibilities

  • Manage and support direct reports.
  • Assist with Non-Conformance Report generation, review, and trending.
  • Track and report key performance indicators such as quality metrics (NCR, competency assessments and CAPAs).
  • Ensure and enable compliance with a quality management system appropriate for the testing performed.
  • Support internal and external audit requests with, but not limited to, procurement of documentation for audits, coordinate subject matter experts, provide lab processing overview and acting as a lab ops representative.
  • Respond to audit findings and coordinate the completion of response plans.
  • Support the Quality Assurance Internal Audit Program and manage the response to findings and recommendations.
  • Manage investigation and action plan implementation of the laboratory operations CAPA program and represent Lab Ops during CAPA Review Board.
  • Partner with the Laboratory Operations Management team in creation and review of controlled documents and templates.
  • Curate and maintain continuing education opportunities for Lab Ops Teams.
  • Manage and maintain new hire paperwork and personnel files for Lab Ops teams.
  • Act as a laboratory operations delegate or representative to internal Biopharma/Alliance Management and ClinOps teams as needed.
  • Participate on cross-functional teams to coordinate troubleshooting, process improvements, and/or implement new workflows or products.
  • Partner with Quality Assurance and other teams to ensure the laboratory follows approved proficiency testing program commensurate with the services offered.
  • Support the continuous improvement of laboratory processes.
  • Travel up to 25% of the time.
  • Other projects and duties as assigned.

Qualifications

Basic Qualifications

  • Bachelor’s degree in a biological, chemical, physical, or life science
  • 6+ years of relevant lab experience in a CLIA/CAP regulation-adherent lab
  • 1+ year(s) of people leadership or team lead experience

Preferred Qualifications

  • Advanced degree in life science, public health, or health administration
  • 2+ years in a leadership role
  • Experience and knowledge of complex NGS laboratory workflows
  • Experience with ensuring and maintaining integrity and quality of the lab (sample processing, equipment, QMS)
  • Experience with internal/external audits
  • Experience writing SOPs and guidelines in the regulated environments referenced above
  • Previous experience in managing or leading a process
  • Demonstrated ability to work in a team environment as well as manage projects and team members effectively
  • Proficiency in MS Office: Word, PowerPoint, Excel
  • Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.)
  • Ability to work well under pressure while maintaining a professional demeanor
  • Ability to prioritize and thoroughly follow up on assigned tasks
  • Ability to handle multiple tasks at once and work in a fast-paced environment
  • Ability to adapt to changing procedures, policies, and work environment
  • Excellent oral and written interpersonal, communication and presentation skills
  • Attention to detail and accuracy
  • Understanding of HIPAA and importance of patient data privacy
  • Demonstrated integrity and a commitment to values held at FMI: 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)

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