Manager, Quality Control

Tempus AI•Research Triangle Park, NC

About The Position

Tempus is seeking a passionate Manager, Quality Control to join their team and advance the healthcare industry through precision medicine. Tempus' proprietary platform connects real-world evidence to deliver actionable insights to physicians, guiding them on the right treatments for the right patients at the right time. This role will manage reagent production and quality control operations to support lab testing, ensuring the availability of qualified reagents for clinical lab processing. The position involves maintaining reagent qualification records, managing quality control of reagent inventory, and optimizing QC workflows with various teams. The manager will also oversee equipment and facilities quality control, ensure safety and environmental requirements are met, and lead a team of supervisors and junior staff. This role is crucial for maintaining the integrity and efficiency of laboratory operations and ensuring compliance with regulatory standards.

Requirements

MS or BS in medical technology, clinical laboratory science, chemical, physical or biological science and at least 7 years of experience
Experience supervising others in a cGMP/ISO or CLIA/CAP high-complexity laboratory
Experience with Next-Generation sequencing and molecular testing methods
Impeccable attention to detail
Ability to develop and implement strategic plans
Excellent communication skills in collaboration with cross functional stakeholders
Thrives in a fast-paced environment demonstrating and ability to adapt to changing circumstances and project priorities
Strong leadership abilities with high standards of personal and professional integrity
Self-driven and works well in an interdisciplinary team with minimal direction
Strong desire to build products that will save lives and change the course of cancer

Nice To Haves

Familiarity with lean manufacturing and acceptance sampling techniques highly desired

Responsibilities

Manage reagent production and quality control operations to support lab testing, including reagent testing, positive control monitoring, planning reagent production/aliquoting, and setting testing criteria for new reagents.
Collaborate with Supply Chain and Lab teams to ensure adequate supply of qualified reagents are available for clinical lab processing.
Maintain reagent qualification records and manage quality control of reagent inventory.
Coordinate and optimize QC workflows with clinical lab operations, supply chain, bioinformatics, and quality assurance for existing and new assays.
Monitor reagent storage conditions and instigate investigations in response to any temperature excursions.
Provide coverage and support for equipment and facilities quality control operations, including IQOQs, PQs, PMs, calibrations, maintenance of SOPs, repairs, and regular maintenance.
Oversee and ensure safety and environmental requirements are upheld, including the appropriate disposal of excess or expired reagents and other hazardous waste.
Lead team of supervisors, individual contributors, and mentor junior staff; provide technical direction and guidance to laboratory employees.
Track control and probe performance trends and investigate incidents.
Review daily, weekly, and monthly QC results and determine the validity of results, perform follow up as needed.
Compile and present QC metrics to management during monthly meetings.
Troubleshoot and ensure corrective actions are taken whenever test systems deviate from the laboratory’s established performance specifications.
Participate in internal and external audits as subject matter expert for QC workflows.
Ensure laboratory practices meet CAP/CLIA/ISO/OSHA regulations.