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.

 

Continuous Quality Improvement Program Manager

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

The Continuous Quality Improvement Program Manager, in the Quality Assurance Laboratory Operations department, is a critical role at FMI ensuring preanalytical laboratory processes are compliant and operating efficiently. This high influence, collaborative, and hands-on position interfaces with Cambridge employees at all levels and functions across the business and provides direct guidance and quality process improvement support to the preanalytical teams. Working with accessioning leaders, staff, and quality assurance, the incumbent ensures compliance with applicable laboratory regulations while leading continuous improvement initiatives. As part of the Quality Assurance Laboratory Operations team, this role ensures laboratory processes are efficient, complaint, and model best practices within a high-quality preanalytical process within the clinical laboratory. This position supports the planning and work of multiple projects with a big picture mindset and is accountable for achieving all related business goals.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.

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

Key Responsibilities

  • Serves as a subject matter expert in preanalytical laboratory workflow, accessioning, and specimen processing in a clinical and biopharma laboratory independently identifies process gaps, recommends, and implements process improvements.
  • Works “at-the-elbow" with the Accessioning Department team to gain a deep understanding of the business needs and supports compliance against certain regulatory standards, focus on people, process, and systems.
  • Participates, guides, and suggests process improvement while ensuring compliance with CAP, CLIA, NYS, CA, and ISO 15189.
  • Contributes and evaluates accessioning standard work ensuring downstream processes and patient care are not negatively impacted and assist with the implementation of new workflow as they are developed while employing change management methodologies.
  • Ensures appropriate tools are applied effectively (e.g., standard work, process maps, the kaizen cycle, material and information flow charts, charter, Gantt charts, status updates, etc.).
  • Performs in-depth analysis of establish business and clinical workflows, identifying areas of opportunity based on risk to patient care in partnership with the Process Excellence teams.
  • In collaboration with the Licensure and Accreditation team, ensures changes to laboratory requirements are communicated and implemented into the preanalytical process.
  • In collaboration with Quality and Accessioning leadership, establishes quality metrics to reflect impact of improvement activities.
  • Establishes strong relationships with laboratory leadership, staff, and interdependent departmental leaders and serves as a resource to other engineers and coordinates all work within the scope of assigned projects.
  • Works with local team members to instill effective daily work management behaviors, such as daily metric review.
  • Applies change management techniques, obtains appropriate buy-in, and addresses the human aspects of change.
  • Contributes toward building a grass-roots culture of continuous improvement.
  • Provides Quality support to internal upstream laboratories.
  • Accountable for exhibiting behaviors as described by FMI Core Competencies.
  • Other duties as required.

Qualifications

Basic Qualifications

  • BS degree in a science-related field with 7+ years of experience in a clinical laboratory; OR
  • MS degree in a science-related field with 5+ years of experience in a clinical laboratory

Preferred Qualifications

  • MT(ASCP) or MT(AMT)
  • Demonstrated experience with Lean Six Sigma Methodology (i.e. 5S, 8S Problem Solving, DMAIC, Visual Management, Value Stream Mapping, Kaizen…)
  • 4+ years of experience in the application of change management methodology
  • Experience in a clinical laboratory including accessioning and specimen receiving departments
  • Familiarity with the College of American Pathologists (CAP) accreditation, CMS regulations, California, and NY DOH licensure requirements and compliance standards and practices preferred
  • Advanced Degree in the Sciences, Engineering, Business, or a related field
  • Advanced statistical and data analysis skills.
  • TQM – Total Quality Management and Lean Six Sigma (LSS) Black Belt experience
  • Deep experience in the principles of quality continuous improvement principles and practices including 5S, 8 Wastes, Standardized Work, Value Steam Mapping, Plan Do Check Act or PDCA, Production Preparation Process or 3P, cycle time, takt time, lead time.
  • Demonstrated experience using structured problem-solving skills uses a systematic, disciplined and data-driven approach that identifies the root causes of various issues and designs solutions to resolve them.
  • Experience with next generation sequencing methodology
  • Evidence of knowledge of accessioning
  • Comprehensive knowledge of Good Manufacturing Practices and Good Documentation Practices
  • Working knowledge of Next Generation Sequencing
  • Member of professional affiliations such as PDA, ASQ, ASCP, AMT
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Demonstrated ability to lead, communicate, interact and influence effectively at technical levels across functions
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Strong skills in troubleshooting and problem solving
  • Understanding of HIPAA and importance of privacy of patient data
  • Commitment to FMI values: patients, innovation, collaboration, and passion

#Hybrid

 

 

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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