Associate Director, Clinical R&D QA (GCP)

Location: Wilmington, Delaware, United States. This role is office-based and requires up to 30% travel.

Company

hirify.global is a global biopharmaceutical company developing and commercializing proprietary therapeutics in Hematology, Oncology, Inflammation, and Autoimmunity.

What you will do

• Provide GCP quality assurance advice and support to Clinical Development, Clinical Operations, and related functions.
• Plan, schedule, and conduct audits of clinical investigator sites, vendors, CROs, Trial Master Files, and clinical submission documents.
• Lead regulatory inspection activities, including pre-inspection audits, inspection readiness, and inspection coordination or hosting.
• Coordinate responses and corrective and preventive actions for deviations, audit findings, and regulatory findings.
• Maintain and improve the clinical Quality Management System, including change control and SOP review and revision.
• Deliver GCP training, mentor junior Clinical QA staff, and communicate clinical compliance issues to Global Clinical R&D QA leadership.

Requirements

• Bachelor’s degree in a science, healthcare-related, or similarly conferred discipline.
• 5–7 years of experience in a pharmaceutical or biopharmaceutical company in a GCP QA or clinical compliance role.
• At least 5 years of experience conducting GCP audits of investigator sites and/or CROs.
• Fluent written and spoken English is required.
• Experience coordinating or playing a key role in regulatory inspections.
• Excellent written and oral communication skills, familiarity with ICH GCP and clinical trial regulations, and the ability to understand advanced operational, scientific, and clinical research areas.

Culture & Benefits

• Office-based position in Wilmington, Delaware.
• Up to 30% business travel.
• Opportunity to support clinical quality across regional and global Clinical Operations initiatives.
• Work within a quality-focused biopharmaceutical R&D organization.