Manager, Quality Assurance

Passionate about precision medicine and advancing the healthcare industry?

Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.

The Manager, Quality Assurance plays an integral role in supporting quality activities related to incidents and issues, including nonconformances (NC), corrective and preventive actions (CAPA) and complaints in accordance with FDA QSR (Quality System Regulation), ISO 13485, and other applicable global regulations. This individual also supports the QMS activities that comply with CLIA/CAP requirements for the clinical laboratories.

Responsibilities include the following. Other duties may be assigned.

• Responsible for overseeing the issue/incident framework that includes NC, CAPA and Complaints systems, ensuring compliance to FDA 21 CFR 820, ISO 13485, CAP/CLIA and other applicable quality system regulations and standards.
• Oversee the activities and development of reporting staff with their day to day NC, CAPA, and complaints management activities.
• Lead process improvements to the issue/incident reporting framework by identifying areas for improvement, simplification, and standardization, ensuring that the various systems are streamlined and aligned.
• Own complaint, adverse event, and medical device reporting (MDR) framework, including refining as needed to support LDTs and medical devices.
• Collaborate with Regulatory on appropriate health authority reporting, as necessary.
• Drive NC and CAPA activities, including investigations, root cause analysis, effectiveness verification, and closure by establishing cross-functional relationships and collaborations with NC and CAPA owners.
• Oversee the issue/incident reporting framework, to support appropriate documentation, training, change controls, and NC/CAPA as necessary to ensure a compliant complaints process.
• Ensure that all potentially reportable complaints are reviewed, escalated and overall managed in a timely and efficient manner.
• Responsible for coordinating and implementing activities to ensure departmental goals for NC, CAPA and Complaints processes are achieved.
• Identify trends and provide metrics to drive root cause analysis and corrective actions to prevent the recurrence of quality issues.
• Own the NC, CAPA and complaint modules and implement updates including participating in validation efforts.
• Establish and generate NC, CAPA and Complaint metrics for management reviews.
• Lead and participate as NC, CAPA and Complaints subject matter expert during internal and external audits.
• Lead and/or support other duties as assigned.

Required Education & Experience:

• Bachelor’s Degree in Engineering or Science field.
• 7 to 10 years of QA experience in a clinical laboratory/medical device/Diagnostic company, with a minimum of 5 years working on Nonconformances, CAPAs and complaints processes.
• Working knowledge of medical device / in vitro diagnostic regulations (e.g., FDA 21 CFR 820, ISO 13485, IVDD, and other applicable quality and regulatory standards).
• QA experience in a molecular testing laboratory (LDTs) is required.
• Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills.
• Ability to work through complex issues and differences in a creative, constructive, and diplomatic manner.
• Ability to manage multiple tasks with limited supervision.
• Ability to demonstrate leadership in helping improve quality processes and create efficiencies for business needs.
• Strong project management expertise and ability to focus on execution of strategic decisions while balancing conflicting priorities.
• Travel may be required up to 20% of the time.