QA Program Manager; GCP, GLP, GVP

• Ways of Working:
  Onsite - This job is fully onsite.
• Employee Type:
  Employee
• Min. Salary Region 1: 151700 USD
• Global Job Level (HCM):
  Professional 4 (11)
• Min. Salary Region 2: 128900 USD

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive
. As a global leader in robotic-assisted surgery and minimally invasive care
, our technologies—like the da Vinci surgical system and Ion
—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare
, you’ll find your purpose here.

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.

• 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.

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…