Senior Manager GD GCP Auditing (GCP)

Location: Ireland; remote work model. The role includes 30–40% domestic and international travel.

Salary: 86,800.00–141,200.00 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.
• Support regulatory inspections and inspection room activities while interpreting policies, standards, and regulations.

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 and 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.
• Ability to manage complex GxP compliance issues independently, collaborate with senior leaders, and communicate effectively.

Culture & Benefits

• Remote work model with collaboration across global development teams, external partners, and quality stakeholders.
• Inclusive workplace culture and equal employment opportunity.
• Competitive total rewards package that may include bonuses, equity awards, pension or retirement benefits, insurance, paid time off, and family support benefits.
• Reasonable accommodations are available during the recruitment process where required.