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.

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