Associate Director (GCP Quality Assurance)

TL;DR

Associate Director (GCP Quality Assurance): Overseeing GCP quality assurance activities for clinical trial operations with an accent on risk management, compliance oversight, and vendor management. Focus on developing audit plans, managing CAPA processes, and ensuring inspection readiness to maintain data integrity and subject safety.

Location: Must be based in or able to commute to Boston, MA (Hybrid or On-Site)

Company

hirify.global is a global biotechnology company dedicated to scientific innovation and the development of transformative medicines.

What you will do

• Lead GCP quality risk management and mitigation strategies for clinical trials.
• Develop and execute risk-based audit plans for internal operations and external vendors.
• Liaise with clinical functions and CROs to ensure consistency and compliance with global regulations.
• Manage investigations, root cause analysis, and CAPA plans to address compliance issues.
• Drive inspection readiness activities and provide consultative guidance on GXP business initiatives.
• Oversee performance management and talent development for the functional area.

Requirements

• B.S. in a scientific or allied health field.
• Minimum 8 years of experience in GCP/GxP Quality Assurance.
• In-depth knowledge of ICH GCP E6 R2 and global regulations (FDA, EMA, MHRA).
• Significant experience across all phases of clinical trial development.
• Strong background in risk management principles and CAPA process requirements.
• Ability to travel up to 15% of the time.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• Generous paid time off including company-wide summer and winter shutdowns.
• Educational assistance programs and student loan repayment support.
• 401(k) retirement plan with company matching.
• Commuting subsidy and charitable donation matching.
• Flexible work environment with hybrid options.