Senior Manager GD GCP Auditing (GCP)

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

Salary: $134,400–$219,200 annually

Company

hirify.global develops science-driven medicines for people with serious diseases.

What you will do

• Lead end-to-end GCP audits across internal and external global development activities.
• Schedule, conduct, report, and follow up on routine and directed audits.
• Develop and execute risk-based audit programs for assigned clinical studies.
• Identify compliance issues and drive process improvements and standardization.
• Represent Quality Assurance on complex compliance projects and initiatives.
• Interpret regulations and support regulatory inspections and inspection-room activities.

Requirements

• Bachelor’s degree and 8+ years of relevant industry experience; a master’s degree is preferred.
• At least 5 years of direct Good Clinical Practice audit experience.
• Expert knowledge of FDA regulations, European Union regulations, ICH guidance, and GCP requirements.
• Experience conducting process, site, vendor, and partner audits.
• Experience with regulatory inspections involving investigator sites, sponsors, or Contract Research Organizations.
• Strong leadership, project management, stakeholder management, collaboration, negotiation, communication, and problem-solving skills.

Culture & Benefits

• Remote work model supporting collaboration with global development teams and external partners.
• Opportunity to contribute to a fast-growing, science-driven organization focused on life-changing medicines.
• Benefits 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.