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 Licensure and Accreditation Lead

  • Torreyana Road, San Diego, California, United States
  • Full Time

About the Job

The Senior Licensure and Accreditation Lead is responsible for coordinating and maintaining continuous compliance with all applicable laboratory requirements, including the coordination of internal compliance audits and alternative assessment programs. This position assists with accreditation activities to ensure adherence to accreditation and regulatory standards, including the College of American Pathologists, NYSDOH, CLIA, CA, and ISO 15189. This role builds and maintains collaboration with the LabOps team and provides suggestions to current practices for compliance. The Sr. Licensure and Accreditation Lead aids FMI departments in the navigation and interpretation of the requirements and provides ongoing education on laboratory accreditation requirements and standards. This position supports the execution of the planning and work of multiple projects. For the San Deigo laboratory, this position serves as the subject matter expert for Califonia laboratory requirements.

Key Responsibilities

  • Ensures inspection readiness through activities including but not limited to maintenance of personnel records, ongoing document preparation and submission for surveys, conducting mock accreditation audits, and tracking corrective action to resolution.
  • Coordinates all accreditation and licensure activities to ensure compliance with applicable regulatory agencies, including facilitating and participating on team evaluation visits to sites seeking initial or reaccreditation.
  • Develops education programs regarding compliance of laboratory regulatory requirements and provides education by utilizing various delivery methods.
  • Coordinates ISO 15189 preparation activities and assists with coordination and execution of the audit.
  • Educates and updates departments regarding accreditation standards, revisions in accreditation standards, and regulatory standards and requirements as identified through internet, literature review, standard review and conference resources.
  • 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.
  • Coordinates delegation process including personnel record audits to ensure compliance with regulatory qualifications, maintaining and coordinating delegation documentation, and review of delegation submissions.
  • Ensures inspection readiness through activities including, but not limited to, maintenance of complete and accurate records, appropriateness, and completeness of competency of testing personnel and support personnel.
  • 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.
  • Ensures that all remedial competency and training is performed for non-complaint proficiency testing.
  • Maintains accurate test menu, proficiency testing events, and maintains the employee rosters for site.
  • Ensures timely gathering and submission of licensure and application materials.
  • Updates regulatory and accreditation policies and procedures in accordance with regulatory requirements, including the notation of the checklist requirement.
  • Actively participates and assists in conducting accreditation training and on-boarding for personnel.
  • Aids federal and state regulatory agencies to related queries regarding licensure and accreditation.
  • Is responsible for tracking, review, maintenance, and supplement tracking of licenses.
  • Ensures that all proficiency testing is reviewed, and corrective action is completed, for all non-conformances.
  • Serves as a liaison for NYSDOH and ensures timely submission of changes via the eCLEP system.
  • Suggests 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.
  • Assists in 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.
  • May be involved in coordination and leading of off-site accreditation inspections as required by the terms of conditions.
  • May provide guidance for licensure and regulatory compliance.
  • May coordinates and manage off-site inspections and assist the on-site teams of inspectors.
  • May assist in special projects, including site implementations, and activities as required.
  • Travel periodically (up to 15%) of the time.
  • Other duties as required.

Qualifications

Basic Qualifications

  • Associate degree in science or related field and 5+ years of experience in the clinical laboratory or healthcare industry; OR,
  • 12+ years of experience in a clinical laboratory
  • Experience working and leading in a clinical laboratory and California Business and Professions Code (BPC 1209 (a) to direct a clinical laboratory offering high complexity genetic molecular biology tests

 

 

Preferred Qualifications

  • Advanced Degree in the Sciences, Engineering or Business or a related field
  • ASCP or MT(AMT) Certification
  • ASQ Certification
  • 7+ years of experience in the clinical laboratory as a Medical Technologist
  • 3+ years of laboratory accreditation/regulatory (e.g., CAP, NYSDOH, CA, CLIA, CMS, ISO 15189) experience and a working knowledge of laboratory operations
  • Experience supporting a CLIA, QC and device laboratory
  • Experience with next generation sequencing methodology
  • Demonstrated capacity to work in a fast-paced environment with strong attention to detail
  • Working knowledge of Next Generation Sequencing
  • Evidence of knowledge of molecular biology
  • Proficiency in Microsoft Office, Word, Excel, Project and PowerPoint
  • Familiarity with the College of American Pathologists (CAP) accreditation, CMS regulations, California, and NY DOH licensure requirements and compliance standards and practices
  • 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)

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