Seeking an experienced GCP QA Program Manager to serve as a hands-on, embedded QA partner supporting clinical research, nonclinical development, and pharmacovigilance activities across early- to late-stage pharmaceutical development programs.
You will work closely with Clinical Research and other 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 ideal for someone who thrives in an interactive, operational environment.
Roles and Responsibilities
- Serve 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-related decision-making using a risk-based, phase-appropriate approach
- Ensure compliance with global regulations across clinical trials, nonclinical studies, and pharmacovigilance activities
- Plan and conduct GCP, GLP, and GVP audits, including internal audits, service provider audits, and study audits
- Support regulatory inspections and maintain ongoing inspection readiness
- Lead deviation investigations, root cause analyses, and CAPA development and implementation
- Qualify and oversee CROs, laboratories, and pharmacovigilance service providers
Basic Qualifications
- 7+ years of GCP/Clinical QA experience in the pharmaceutical or biotechnology industry
- Demonstrated experience conducting GCP, GLP, and GVP audits
- Strong knowledge of FDA, EMA, and ICH regulations and guidelines
Preferred Qualifications
- Experience supporting early- to late-stage nonclinical, clinical, and drug safety development programs
- Experience supporting regulatory inspections
- Experience auditing service providers, nonclinical and clinical research sites, CROs, and internal processes
