Senior Director, Clinical Quality Assurance (CQA)

Location: Remote, United States

Base salary: $245,000–$286,000 annually

Company

hirify.global is a biotechnology company developing targeted gene therapies and proprietary AAV vectors for rare and large-market diseases.

What you will do

• Provide strategic and operational Quality Assurance leadership for multiple registrational, global clinical trials.
• Ensure clinical trials are conducted in compliance with international Good Clinical Practice requirements.
• Advance risk-based quality oversight and continuous improvement of clinical quality systems.
• Lead or oversee the investigation and management of significant clinical study quality events.
• Champion a collaborative culture of quality, learning, and open communication.
• Lead preparedness, readiness, and management of BIMO and GCP inspections.

Requirements

• Relevant clinical quality assurance leadership experience in the biotechnology or pharmaceutical industry.
• Experience overseeing global clinical studies and clinical quality systems.
• Knowledge of international Good Clinical Practice requirements.
• Experience with risk-based quality oversight, quality event investigations, and inspection readiness.
• Ability to travel 5%.

Culture & Benefits

• Remote work arrangement within the United States.
• Collaborative environment focused on innovation and individual contribution.
• Performance recognition and generous benefits.
• Opportunities for challenging career development in gene therapy.