May 19, 2021

Director, Quality Control

  • Freenome
  • South San Francisco, CA

Job Description

As the Director of Quality Control you will join a highly collaborative team and make an immediate impact on early cancer detection. You will support Freenome’s mission by establishing a quality control organization within Laboratory Operations and build a team that will leverage both internal and external capabilities to enable QC testing needs for Freenome's multiomics IVD including continuous improvements. The high complexity nature of the work demands an in-depth understanding of reagent and consumable QC testing, analytical methods, statistical analysis and technology, and regulatory requirements. The work requires keeping meticulous and organized records, excellent attention to detail, the ability to prioritize and be flexible with multiple tasks and schedules. How you’ll contribute: Establish a quality control organization within Laboratory Operations and build a team that will leverage both internal and external capabilities to enable both routine and unique QC testing needs for Freenome’s multiomics IVD including continuous improvements. Collaborate with the development team to develop Quality Control strategy and direction on new and existing analytical methods and provide support for verification, validation and transfer activities. Responsible for investigation and resolution of reagent/consumable-related issues , including impact assessment, root cause analysis, and implementation of corrective and preventive actions and continual monitoring of its effectiveness. Responsible for ensuring reagent and consumable testing is performed and analyzed according to established manufacturing and incoming QC work instructions. Draft, review and update reagent quality control documentation (SOP, batch records, work instructions, test methods, etc.) and any planned or unplanned deviations. Ensure consistent compliance with applicable federal, state and local regulations and quality-related best practices in development, validation, use, and documentation of analytical and functional test methods for reagent lot qualification, stability studies, and related activities. Review and manage stability studies, validation protocols, other process improvements, and new assay projects Responsible for supporting the development, implementation, and continual improvement of quality control aspects of the quality management system. Provide support in audits, including vendor qualification audits, and self inspections of quality control areas. Control and manage Quality Control budget including preparation, monitoring and adherence to Freenome’s strategy. Hire, mentor, motivate, and provide direction to the Quality Control team Ensure the environment for employees is safe from physical, chemical, and biological hazards, and that safety and biohazard requirements are followed and is responsible for reporting all quality and safety concerns to the Laboratory Director or Safety Officer. What you’ll bring: Minimum 10 years of industry laboratory setting OR biochemical and molecular assays Minimum 3 years of leadership or mentorship experience in reagent manufacturing and/or quality control Masters or Bachelor in chemical, physical, biological science, or related field Proficient in a variety of basic, intermediate, and advanced laboratory skills Proficient with NGS or multiplex protein assays and demonstrated ability to analyze and problem solve complex issues impacting reagent performance Comprehensive knowledge of Current Good Manufacturing Practices (CGMP), ISO 13485, 21 CFR part 820, and other medical device (IVD) regulations in addition to working knowledge of local, state, and federal laboratory regulations Strong communicator with ability to maintain open communication with internal employees, managers, and customers as needed Ability to prioritize and drive to results with a high emphasis on quality Ability to work as part of a cross functional team Ability to provide direct supervision to the QC team Strong analysis, including process statistics, and problem-solving skills Strong technical skills and job and industry knowledge Ability to proactively communicate consistently, clearly, and honestly Strong automation, computing skills, and project management abilities

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