GLP/GCLP Quality Professional Location: South San Francisco, CA/ Hybrid Duration: 6 months Description: Project Overview: We are focused on generating and activating data from a variety of sources, including clinical, social, behavioral and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Our unique expertise and capabilities in technology, data science and healthcare enable the entire healthcare ecosystem to drive better health outcomes. Overall Responsibilities: As a GLP/GCLP Quality Professional, you will work with the organization to act as a champion of Quality Assurance activities for development and commercial laboratory services and projects. You will support the implementation and maintenance of quality programs, systems, and operations related to Good Laboratory Practices (GLP) and Good Clinical Laboratory Practices (GCLP). You will help develop phase-appropriate quality strategies during different phases of product development, from research to pre-clinical and clinical phases. You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met as applicable. This is a hands-on role where you will apply intensive, self-directed, and diversified knowledge of laboratory and quality principles for programs and platforms. Top 3 Daily Responsibilities: Guide and train laboratory personnel in adhering to GLP/GCLP, when applicable. Review and approve laboratory procedures, changes to LIMS, and data. Facilitate phase appropriate GxP compliance for test method development and validation; sample handling, processing and storage; equipment calibration and maintenance; data integrity; and documentation. Top Skills: Someone who has experience in LIFE science, has good laboratories practices. Someone who can understand, and able to train and monitor. Someone who can conduct lab training and write SOP’s. Required minimum 7+ years of experience. Skill/Experience/Education : Mandatory: BA/BS degree in science, life sciences, related technical field, or equivalent practical experience. 5+ years of experience in R&D Quality or product development in the pharmaceutical, biotech, life sciences, or clinical research industries. Expertise in GLP or GCLP highly preferred . Experience with Laboratory Quality Management Systems (QMS) and LIMS Knowledge of ISO/IEC 17025 – Testing and Calibration Laboratory Requirements. Experience in project management, training, and working collaboratively with product development teams. Experience with digital health. Experience working with Client technologies in a lean, fast-paced, and highly innovative environment. Demonstrated ability to implement and improve QMS processes using industry best practices, tools, and agile/scrum/iterative methodology. Excellent organizational, interpersonal and verbal and written communication skills, with the ability to deliver quality outputs under minimal supervision.