QA Program Manager (GCP, GLP, GVP)

Intuitive • Sunnyvale, CA

1d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager