You will build strategic partnerships leading risk-based quality audits across investigator sites, service providers, and internal processes, ensuring our clinical studies meet the highest standards of GCP compliance, while collaborating with study teams, cross-functional partners, and regulatory colleagues around the world.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
• Location: US (Multiple locations are being considered for this role)
• Work model/flexibility: Remote
• Travel percentage: Ability to travel 30–40% of the time, both domestically and internationally
Discover your role:
• Own the end-to-end audit process — scheduling, preparing, conducting, reporting, and following up on routine and directed audits
• Lead a range of audit types across sites, vendors, license partners, and internal processes globally
• Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve a variety of GCP compliance issues
• Represent GDQA on cross-functional teams and complex compliance projects spanning multiple departments
• Interpret regulations and quality standards, evaluating critical issues that fall outside existing guidance
• Support clinical study teams by developing and implementing risk-based audit strategies
• Step into regulatory inspections as part of the control or inspection room team when needed
• Mentor and help onboard new GDQA staff, sharing your auditing expertise
This role requires:
• Bachelor's degree with 6+ years of relevant industry experience including 4+ years of direct GCP audit experience. Background supporting risk-based audit strategy development for clinical studies
• Experience applying FDA and EU regulations including ICH E6 R3 and applicable standards.
• Ability to effectively manage multiple complex priorities and make complex decisions with a sense of urgency
• Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
Salary Range (annually)
$114,800.00 - $187,400.00
