Passionate about making a difference in healthcare and technology?
Tempus is a medical technology company that is making precision medicine a reality by gathering and analyzing clinical and molecular data at scale. Through the power of artificial intelligence, we believe all patients will eventually be on their own personalized therapeutic path, enabling longer and healthier lives. We're on a mission to redefine how genomic data is used in clinical settings by building the systems necessary to help usher in precision medicine. Tempus combines deep information technology development expertise and a state-of-the-art genomics sequencing laboratory. We’re looking for a creative and mission-driven Director of Quality Assurance who will help us continue our fast pace of growth and innovation while maintaining excellence in quality and meeting our regulatory obligations.
What you’ll do:
Have a leadership role in building and implementing a quality system for innovative new products, including advanced diagnostic tests, clinical decision support software, and artificial intelligence algorithms.
Oversee a nimble Quality Assurance team that promotes a culture of continuous improvement and meets the quality requirements for our laboratory and software development/bioinformatics operations.
Develop a strategic direction for the Quality Assurance team that tracks the objectives of our business as a whole and fits in the big picture.
Build and maintain a quality system that meets relevant regulatory and certification regimes including QSR (21 CFR 820), ISO, and other quality standards while supporting high-throughput and rapid-cycle innovation.
Adapt processes and systems over time to accommodate new initiatives, meet the needs of internal stakeholders, and support our fast pace of growth.
Develop and track key performance metrics and make regular reports to our executive team, operationalizing leadership direction quickly and efficiently.
Identify the root causes of problems and make system-level changes to address them.
Manage interactions and relationships with a wide variety of on- and off-site auditors and regulators.
Collaborate cross-functionally with internal departments on strategy and implementation of quality and regulatory initiatives.
Assess product, compliance, and operational risks and develop risk management strategies that align with broader strategic objectives.
Review and provide input on policy changes that could affect Tempus’ operations.
Model a can-do and mission-driven attitude and willingness to take on new tasks, projects, and responsibilities.
Experience working with innovative medical devices or diagnostics that include advanced software functions.
Management of technical and scientific experts and ability to lead, influence, create and work within cross-functional team environments
Compliance-oriented focus and working knowledge of regulatory expectations and how to maintain strong regulatory relationships.
Responsive to feedback, willing to change direction, and able to identify creative solutions to meet business and regulatory needs
Highly organized and systematic, superb attention to detail and ability to get things done quickly and accurately
Practical knowledge of medical device and clinical laboratory regulations and standards (e.g., FDA, European and Canadian medical device regulations, ISOs 13485, 14971, 62304, CLIA and the like) and the ability to translate abstract requirements into a real-world setting
Minimum of 7 years of quality management experience
Bachelor’s degree required