Director of Product Quality and Compliance at Tempus
Passionate about making a difference in healthcare and technology?
With the advent of genomic sequencing, we can finally decode and process our genetic makeup. We now have more data than ever before, but providers don't have the infrastructure or tools to make sense of this data. 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 by combining that data with other data such as structured clinical data and imaging data. To do that, Tempus combines deep information technology development expertise and a state of the art genomics sequencing laboratory. We are looking for a creative and mission-driven Director of Product Quality and Compliance 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:
- Oversee a nimble Quality Assurance team that promotes a culture of continuous improvement and meets the needs of 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 (CLIA, CAP, NYS, ISO, and other 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 software as a medical device (SaMD), software in a medical device (SiMD), or other health apps or information technology
- Ability to lead, influence, create and work within cross-functional team environments
- 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 regulations and standards (e.g., FDA, European and Canadian medical device regulations, ISOs 13485, 14971, 62304 and the like) and the ability to translate abstract requirements into a real-word setting
- Minimum of 7 years of quality management experience
- Bachelor’s degree required