We are seeking an experienced GCP, GLP, and GVP Quality Assurance Program Manager who will serves as a hands-on, embedded Quality Assurance resource supporting clinical research, nonclinical, and pharmacovigilance activities for early- to late-stage pharmaceutical development focused on fluorescence imaging technologies. This role works directly with Clinical Research and other cross-functional teams on-site, providing day-to-day quality guidance, real-time issue resolution, and active participation in study execution. The position requires demonstrated experience conducting GCP, GLP, and GVP audits and is designed for a quality professional who thrives in a highly interactive, operational environment rather than a purely oversight-based role. Roles and Responsibilities -Act as an on-site QA partner embedded within Clinical Research and development teams Provide real-time, hands-on quality guidance during study planning, execution, and close-out Support quality decision-making using a risk-based, phase-appropriate approach Support clinical trials, nonclinical studies, and pharmacovigilance activities in compliance with global regulations Plan and conduct GCP, GLP, and GVP audits (internal, service provider, and study audits) Support regulatory inspections and inspection readiness activities Lead deviation investigations, root cause analyses, and CAPA implementation Qualify and oversee CROs, laboratories, and PV service providers
Basic Qualifications Bachelor’s degree in Life Sciences or related discipline 7+ years of pharmaceutical or biotech QA experience Direct experience conducting GCP, GLP, and GVP audits Strong knowledge of FDA, EMA, and ICH requirements Preferred Qualifications: Experience supporting early- to late-stage nonclinical, clinical and drug safety development programs Experience with imaging agents, diagnostics, or combination products Regulatory inspection experience Service provider, non-clinical and clinical research sites, CRO, internal process audits and inspection support.
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 reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee. This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate’s experience, knowledge and skills. Compensation will be based primarily on the job level at which the role is filled and the candidate’s qualifications, consistent with applicable law. We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.