The Quality Management System Development and Program Manager is responsible for supporting the design, implementation, and continuous improvement of the Quality Management System (QMS), including training and electronic QMS (eQMS) components, supporting early- to late-stage pharmaceutical development organization. This is an individual contributor, program-management role with no direct reports but one that requires the incumbent to work cross-functionally in a highly collaborative and supportive environment to ensure effective implementation of Intuitive Fluorescence Imaging’s Quality Management System across all functional areas and GxP disciplines. The position plays a hands-on role supporting the selection, validation, and implementation of QMS processes and enabling systems, including eQMS platforms, while working closely with cross-functional stakeholders to ensure regulatory compliance and operational effectiveness. Key Responsibilities Support the design, implementation, and maintenance of the enterprise QMS in alignment with FDA, EMA, and ICH requirements Develop and manage core QMS elements including SOPs, work instructions, templates, and controlled records Support the selection, validation, configuration, and implementation of QMS processes and enabling systems, including eQMS components Establish and maintain the Training Management System (LMS) as an integrated component of the QMS Define training requirements, curricula, role-based training matrices, and training effectiveness measures Ensure timely assignment, completion, tracking, and documentation of GxP training Lead SOP lifecycle management, including authoring, review, approval, periodic review, and retirement Establish and maintain document control, change management, deviation, and CAPA processes Support root cause analysis, CAPA development, effectiveness checks, and closure Establish QMS governance processes including management review, quality metrics, and reporting Support internal audits, vendor audits, and inspection readiness related to QMS and training compliance Ensure QMS and LMS documentation supports regulatory inspections and partner audits Provide hands-on QMS and training guidance to cross-functional teams
Required: Bachelor’s degree in Life Sciences or related discipline 7+ years of experience in pharmaceutical or biotechnology quality assurance Direct experience building, implementing, or significantly enhancing a QMS Experience supporting selection, validation, and implementation of QMS processes and/or eQMS platforms Hands-on experience implementing or managing a Training Management System (LMS) Strong working knowledge of FDA, EMA, and ICH GxP requirements Experience with SOP management, CAPA, deviation management, and change control Preferred: Experience supporting early- through late-stage development programs Experience integrating QMS, LMS, and eQMS requirements across GCP, GLP, GVP, and CMC Experience preparing organizations for regulatory inspections Familiarity with common eQMS platforms
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role. Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. Mandatory Notices U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status. Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process). For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws. Preference will be given to qualified candidates who do not reside, or plan to