Position Code: 12-PD-058
Reports To: Vice President, Operations
The Lab Director is responsible for providing overall direction and management of Complete Genomics’ laboratory operations. This includes ensuring the quality of data provided, compliance to CLIA/CAP and other related requirements, and building the appropriate organization to meet business requirements.
• Providing direction and leadership to employees in the labs
• Working with cross-functional teams to ensure that our Quality Management System (QMS) is developed and implemented for all phases of testing, to include the pre-analytic, analytic and post-analytic phases of testing as well as general lab systems
• Ensuring test systems have established acceptable performance specifications for the performance characteristics of accuracy, precision, analytical sensitivity, and analytical specificity of the system, to include performance, maintenance and calibration of instrumentation and equipment used to perform the testing.
• Ensuring policies and procedures are established to monitor processes; and when indicated, remediate, take corrective actions and document when problems are identified with the analytical test methods.
• Ensuring policies and procedures are established for hiring, training and monitoring people who conduct pre-analytic, analytic, and post-analytic phases of testing to assure they have the appropriate education and experience, are competent and maintain their competency to perform the testing procedures.
• Ensuring the labs have established approved Proficiency Testing (PT) programs to include an approved corrective action plan when any PT results are determined to be unacceptable.
• Managing a complex process spanning molecular biology, surface chemistry, and DNA sequencing in high volume biochemistry operations, including automated processes and complex, multistep chemistry in a dynamic environment.
• Providing strong leadership in cross functional teams.
• Plans and administers directly and through supervisory personnel the effective delivery of whole genome sequencing data in accordance with all regulatory agency standards.
• Oversees the development and maintenance of quality control programs necessary to ensure all procedures are performed properly and that the results are valid and accurate prior to release.