Manager, Quality Assurance Auditor – GCP

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the complete audit process, which encompasses scheduling, preparation, execution, reporting, and follow-up.

• Direct routine and targeted audits across investigator sites, vendors, license partners, and internal processes on a global scale.

• Utilize FDA, EU, and ICH regulations to address GCP compliance matters.

• Act as a representative of GDQA on cross-functional teams and complex compliance initiatives.

• Analyze regulations and quality standards while assessing issues that fall outside existing guidance.

• Formulate and execute risk-based audit strategies in collaboration with clinical study teams.

• Engage in regulatory inspections as part of control or inspection room teams.

• Provide mentorship and onboarding support for new GDQA personnel.

⛳️ Requirements

• A Bachelor's degree is required.

• A minimum of 6 years of relevant industry experience, including at least 4 years of direct GCP audit experience.

• Experience in supporting the development of risk-based audit strategies for clinical studies.

• Proficiency in applying FDA and EU regulations, including ICH E6 R3 and related standards.

• Capacity to juggle multiple complex priorities and make urgent, complex decisions.

• Excellent project management, stakeholder management, collaboration, and negotiation skills.

• Willingness to travel 30–40% of the time, both domestically and internationally.

🏝️ Benefits

• Annual bonuses or other incentive programs.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness initiatives.

• Access to fitness centers.

• Comprehensive medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Flexible remote work model.