Manager, GCP Auditing (GCP)

Location: United States; remote work model with 30–40% domestic and international travel

Salary: $114,800–$187,400 annually

Company

hirify.global develops medicines for people with serious diseases through science and innovation.

What you will do

• Own the end-to-end process for routine and directed audits, including scheduling, preparation, execution, reporting, and follow-up.
• Lead audits across investigator sites, vendors, license partners, and internal processes globally.
• Apply FDA, EU, and ICH regulations to resolve complex GCP compliance issues.
• Represent Global Development Quality Assurance on cross-functional teams and compliance projects.
• Develop and implement risk-based audit strategies for clinical studies.
• Support regulatory inspections and mentor new quality assurance staff.

Requirements

• Bachelor’s degree and 6+ years of relevant industry experience.
• At least 4 years of direct GCP audit experience.
• Experience developing risk-based audit strategies for clinical studies.
• Experience applying FDA and EU regulations, including ICH E6 R3 and applicable standards.
• Strong project management, stakeholder management, collaboration, negotiation, and complex decision-making skills.
• Ability to work remotely from the United States and travel 30–40% domestically and internationally.

Culture & Benefits

• Inclusive workplace focused on collaboration and meaningful impact for patients.
• Comprehensive total rewards package may include annual bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodations are available during the recruitment process where required.