As a member of the quality team, the Quality Auditor II works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and to support a diverse array of projects and initiatives. This position contributes to QA activities across multiple quality system requirements, such as CLIA/CAP, GCP, ISO and FDA regulated environments.
Perform periodic audits of FMI laboratory Good Clinical Practice (GCP) activities which may include, but is not limited to, BioPharma and Clinical Operations procedures, processes, records, reports, and applicable laboratory operations.
Lead audits independently; lead a team of auditors.
Establish and/or contribute to the GCP Internal audit schedule Plan; conduct GCP audits as defined by the schedule.
Prepare and issue audit reports.
Discuss audit findings with management to develop appropriate corrective and preventive actions where appropriate.
Support external audits performed by regulatory/inspection agencies, BioPharma/Clinical Operations Partners, as required.
Assist with the compilation of audit metrics for management purposes.
Demonstrate strong proficiency in the application of the Corrective and Preventive Action (CAPA) system to ensure action, closure and verification of effectiveness of solutions applied to root cause issues originating from internal/external quality audits or other sources.
Maintain current and accurate records of all relevant communications, audits, corrective action plans, and CAPA effectiveness monitoring, as required.
Maintain familiarity with FDA, ISO, IVDR, ICH, BioPharma, Clinical Operations and relevant Laboratory operating and quality assurance/quality control procedures to effectively perform GCP quality assurance functions.
Support, maintain and continually improve Quality System.
Maintain availability to work outside of a regularly scheduled shift.
Travel domestically and internationally up to 25% of the time.
Support other duties, as assigned.
5+ years of clinical monitoring/Quality Assurance/Auditing experience in the medical device, clinical laboratory, pharmaceutical, biotechnology, or diagnostic industries
Experience with managing GCP activities across multiple quality system requirements (e.g. operating under FDA, ISO, CLIA and CAP)
Experience or familiarity with Medical and Invitro Diagnostics, Companion Diagnostics or Clinical Lab operations
Understanding/working knowledge of ICH and GCP guidelines
Ability to manage multiple projects and work independently
Process-oriented, with the ability to demonstrate good judgment and decision-making
Ability to identify quality issues and effectively interface with internal and external teams
Ability to communicate clearly and concisely with all stakeholders
Strong attention to detail and the ability to manage multiple priorities with aggressive timelines
Strong written and communication skills
Understanding of HIPAA and importance of privacy of patient data
Commitment to FMI values: patients, innovation, collaboration, and passion
#LI-Remote (Cambridge, Massachusetts, United States)
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.
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)