Director, Global Clinical Quality

TL;DR

Director, Global Clinical Quality: Ensuring global clinical quality oversight across protocol startup, execution, and closeout with an accent on risk-based and Critical to Quality strategies, data integrity, and regulatory preparedness. Focus on leading quality improvements, mentoring operational and quality leads, escalating serious issues, and investigating trends and risks through root-cause analysis.

Location: United States of America

Salary: $151,000 USD minimum base pay annually

Company

hirify.global supports biotech, medtech, and specialty pharma companies in delivering new medicines, devices, and diagnostics.

What you will do

• Ensure each BU Quality Lead performs protocol assessments and manages Critical to Quality and data/process safety and data integrity risks across the study lifecycle.
• Develop and implement initiatives to assess clinical quality risks, identify gaps, and drive identification, mitigation, and prevention.
• Provide quality oversight, mentorship, and guidance to operational teams, including initial risk assessments and systematic corporate/clinical governance and risk management.
• Ensure timely communication and escalation of serious issues and signals of concern via action plans.
• Oversee documentation of review observations and investigate trends, issues, and risks using root-cause analysis.

Requirements

• Bachelor’s degree in Life Sciences or related field.
• 5–7 years in a lead operations role at a clinical site/system research facility and 5–7 years of industry experience in a quality leadership role.
• Strong knowledge of ICH-GCP, FDA, ISO, and other global regulatory requirements.
• Expertise in Risk-Based and Critical to Quality strategies at the clinical trial level throughout the project lifecycle.
• Strong computer skills and ability to adopt new technologies.
• Demonstrated leadership and mentorship experience with a proactive Quality by Design approach.

Culture & Benefits

• Comprehensive benefits package may include health insurance, retirement plans, and paid time off.
• Annualized minimum base pay of $151,000 USD, with final compensation based on qualifications and role fit.
• Emphasis on growth, flexibility, and work-life balance.
• Quality leadership role with influence on how work is done and where ideas matter.

Hiring process

• Interviews to assess clinical quality leadership experience, regulatory knowledge, and risk-based quality approach.
• Evaluation of leadership/mentorship capabilities and ability to drive continuous regulatory preparedness.