Job Description
About the Job
The Senior Clinical QA Lead plays a key role as the Audit Lead in Biopharma Qualification Audits and select Partner Routine Audits. The Audit Lead is responsible for the successful execution of the audit including audit prep activities such as the pre-audit call facilitator, Internal Audit Prep Meeting Lead, and the Audit itself. Audit Leads act as a Point of Contact during the audit for internal stakeholders ensuring audit objectives are met.
This position works collaboratively with groups throughout the organization to ensure compliance with regulatory requirements and support a diverse array of projects and initiatives. The Clinical QA Lead contributes to QA activities across multiple quality system requirements (CLIA/CAP, GCP, ISO and FDA regulated environments).
Key Responsibilities
* Lead Biopharma Qualification and Routine Audits, as requested.
* Support external audits performed by regulatory/inspections agencies.
* Facilitate audit/inspection readiness training and activities.
* Track and manage pre-audit deliverables to ensure timely fulfillment.
* Support the communication of audit observations/recommendations
* Support the preparation of audit responses.
* Support the compilation of audit metrics.
* Assist in the internal GCP activities, such as internal audits.
* Contributes to the development of controlled documentation, as needed.
* Travel domestically up to 10% of the time.
* Support other QA duties as assigned.
Qualifications
Basic Qualifications
* Bachelor's Degree in a science or engineering discipline and 5+ years of experience in the medical device, diagnostics, or biopharmaceutical industry with direct involvement in clinical trials; OR
* Master's Degree in a science or engineering discipline with 3+ years of experience
Preferred Qualifications
* Experience or familiarity with Medical Devices
* Knowledge of Good Clinical Practice (GCP)
* Demonstrated ability to maintain accurate audit records
* Knowledge of Microsoft Office applications (e.g. Word, Excel, Powerpoint)
* Knowledge of root cause analysis and corrective and preventative action
* Ability to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements
* Ability to effectively communicate verbally and in writing within the team and with other functional teams
* Ability to cooperate and collaborate effectively with a team
* Highly detail oriented
* Excellent time management skills and ability to deliver requested tasks on time
* Understanding of HIPAA and importance of privacy of patient data
* Commitment to FMI values: patients, innovation, collaboration, and passion.
#LI-Hybrid
About Us
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)