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.

 

Manager, Licensure and Accreditation

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

About the Job

The Accreditation and Licensure Manager is responsible for driving the accreditation and licensure processes and for internal and external laboratory audit preparation, ensuring continued compliance and regulatory certification to all required laboratory licensure standards. This position guides accreditation activities to ensure adherence to accreditation and regulatory standards, including the College of American Pathologists, NYSDOH, CLIA, CA, and ISO 15189. As a subject matter expert of laboratory standards, this position guides key stakeholders in decision making to ensure ongoing compliance. The Accreditation and Licensure Manager 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.

Key Responsibilities

• Drives all accreditation and licensure activities to ensure compliance with applicable regulatory agencies including organizing, facilitating, and participating on team evaluation visits to sites seeking initial or reaccreditation.

• Educates and updates Laboratory Directors, leadership and staff regarding accreditation standards, revisions in accreditation standards, and regulatory standards and requirements as identified through internet, literature review, standard review and conference resources.

• Ensures inspection readiness through activities including, but not limited to, maintenance of complete and accurate records, ongoing document preparation and submission for surveys, conducting mock accreditation audits, and tracking corrective action to resolution based on assessed levels of readiness and compliance.

• Coordinates and manages off-site inspections and assists the on-site teams of inspectors.

• Prepares data for the Quality Management Review with status of pending laboratory inspections and deficiency metrics.

• Provides guidance for laboratory licensure and regulatory compliance.

• Ensures timely gathering and submission of licensure and application materials.

• Develops/updates regulatory and accreditation policies and procedures in accordance with regulatory requirements including the notation of the checklist requirement for all Quality documents within the Document Control system.

• Participates in coordination and leading of off-site accreditation inspections as required by the terms of conditions.

• Serves as a liaison to aid federal and state regulatory agencies to related queries regarding laboratory licensure and accreditation.

• Tracks, reviews, maintains, and supplements tracking of licenses.

• Promotes internal and external customer satisfaction and a culture of service excellence by meeting the customer’s quality expectations.

• Ensures that all proficiency testing is reviewed, and corrective action is complete for all non-conformances.

• Ensures that a defined instrument to instrument, method to method, and laboratory to laboratory comparison process, with fixed criteria for accessing acceptability, is performed and documented at least semi-annually.

• Ensures laboratory compliance including, but not limited to, oversight of testing personnel competency execution, laboratory process training, rotation of PT, maintenance log review.

• Collaborates with Laboratory Management to suggest and implement changes in working conditions and develops and establishes measures to improve efficiency and performance of the laboratory; strives to make the laboratory a model of efficiency, quality, safety, and service.

• Conducts 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.

• Supervises. develops and mentors quality professionals, including ensuring activities are completed in alignment with goals and continuous development of personnel.

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

• Ensures the work climate/culture within Quality System, exemplifies our Company's Leadership behaviors.

• May assist in special projects, including site implementations, and activities as required.

• May lead remote teams.

• Travel periodically (up to 20%).

• Other duties as required.

Qualifications

Basic Qualifications

• Bachelor’s degree in a healthcare related field

• 5+ years of clinical laboratory experience, including 3+ years of laboratory accreditation/regulatory (e.g., CAP, NYSDOH, CA, CLIA, CMS, ISO) experience

• 3+ years of management experience

Preferred Qualifications

• Advanced Degree in the Sciences, Engineering or Business or a related field

• ASCP or MT(AMT) Certification

• ASQ Certification

• Experience supporting a CLIA, QC and device laboratory

• Experience with next generation sequencing methodology

• 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

• Evidence of knowledge of molecular biology

• Working knowledge of Next Generation Sequencing

• Working knowledge of laboratory operations

• Familiarity with the College of American Pathologists (CAP) accreditation, CMS regulations, California, and NY DOH licensure requirements and compliance standards and practices

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

• Strong skills in troubleshooting and problem solving

• Excellent communication skills and proven ability to work effectively as a member of a multidisciplinary team

• Understanding of HIPAA and the importance of patient data privacy

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

 

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)

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.