Associate Director, Clinical Quality Assurance (GCP)

Location: Remote; travel of up to 20% may be required.

Salary: $154,500–$195,700 USD per year.

Company

hirify.global is an ophthalmology company developing and commercializing innovative therapeutics focused on preventing blindness and treating serious retinal diseases.

What you will do

• Lead and continuously improve the clinical quality management system in alignment with FDA, ICH, GCP, and other applicable global requirements.
• Provide quality oversight for clinical studies, including document reviews, quality metrics, risk assessments, deviations, and non-conformances.
• Plan and oversee audits of clinical investigator sites, clinical documents, clinical systems, databases, and vendors.
• Support FDA and health authority inspections, including BIMO inspection readiness initiatives.
• Develop quality documentation, update procedures, train personnel, and communicate quality status to Leadership.
• Collaborate with Clinical Operations, Clinical Development, Biometrics, Pharmacovigilance, Leadership, and external partners.

Requirements

• Bachelor’s or advanced degree in a scientific discipline.
• At least 10 years of related experience in the pharmaceutical or biotech industry.
• At least 8 years of related GCP quality assurance experience at a CRO, biotech, or pharmaceutical company.
• Extensive knowledge of ICH Guidelines and international regulatory requirements for clinical development programs.
• Experience interacting with or leading regulatory health authorities in pre- and post-approval settings.
• Extensive experience auditing vendors, clinical trial documents, and clinical investigator sites, along with strong risk analysis and quality systems expertise.

Culture & Benefits

• Remote work arrangement with travel required for partnerships and role execution.
• Culture centered on transformational innovation, integrity, compassionate excellence, and inclusive collaboration.
• Opportunity to contribute to therapeutics aimed at improving patient vision and preventing blindness.
• Inclusive equal opportunity workplace committed to a diverse workforce.