Auditor - GCP

Location: Onsite in King of Prussia, Pennsylvania, United States; the role includes up to 50% travel.

Company

hirify.global is a global biotherapeutics company developing therapies across immunology, hematology, cardiovascular and metabolic, respiratory, and transplant areas.

What you will do

• Execute external GCP audits of clinical investigator sites, CROs, electronic-system providers, and institutional review boards or ethics committees.
• Prepare comprehensive audit reports, categorize findings by risk level, and recommend corrective and preventive actions.
• Identify non-compliance trends and systemic risks affecting clinical research and data integrity.
• Work with clinical stakeholders and functional leads to develop risk-based, compliant solutions and improve trial management.
• Support improvements to standard operating procedures for audit conduct and maintain current knowledge of global GCP requirements.

Requirements

• Bachelor’s degree in biological science, another scientific discipline, or a related field.
• At least 3 years of quality assurance experience in a GCP-regulated environment.
• Experience with clinical audits and inspection management, including clinical trial phases, monitoring, and quality assurance requirements.
• Working knowledge of ICH E6 R3, 21 CFR Parts 11, 50, 312, and 812, and applicable European clinical trial regulations and directives.
• Strong analytical, problem-solving, interpersonal, and negotiation skills, with the ability to work with limited supervision.

Culture & Benefits

• Work with multinational clinical teams, investigators, and external CROs.
• Contribute to therapies addressing unmet medical needs across multiple therapeutic areas.
• Benefits are provided through CSL’s employee well-being program.
• Inclusive workplace focused on belonging, curiosity, empathy, and a diverse workforce.