Senior Clinical QA Lead

Job Details

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

Preferred Qualifications

#LI-Hybrid

Company

Foundation Medicine was founded in 2010 with a mission to bring deep molecular information to the point of care for every patient living with advanced cancer.

Company info

Website Phone 617-418-2200 Location One Kendall Square

Suite B3501

Cambridge

Massachusetts

02139

United States

Share this job