Senior Director, GCP Quality Assurance

Location: Boston, Massachusetts, United States; hybrid schedule with at least two onsite days per week, currently Tuesday and Wednesday. Travel of 20% or more may be required.

Salary: $266,000–$344,000 USD per year, depending on location, experience, qualifications, and other job-related factors. Annual bonus and long-term incentive awards may be available.

Company

hirify.global is a clinical-stage biotechnology company developing precision therapies for autoimmune and inflammatory diseases.

What you will do

• Define and mature the GCP Quality Assurance strategy for clinical development programs.
• Provide senior QA partnership to Clinical Operations, Regulatory Affairs, Pharmacovigilance, Data Management, Biostatistics, CROs, and other service providers.
• Lead GCP quality systems, risk management, quality metrics, SOPs, training materials, and quality-by-design processes.
• Own risk-based audits covering CROs, investigator sites, vendors, TMF/eTMF, systems, and processes.
• Lead inspection readiness, mock inspections, inspection conduct, response development, CAPA planning, and regulatory observation follow-up.
• Build, mentor, and scale internal or external GCP QA capabilities.

Requirements

• Bachelor’s degree in a scientific or related discipline; an advanced degree is preferred.
• 12+ years of progressive GCP Quality Assurance or Clinical Quality experience in a biotech, pharmaceutical, or CRO environment, including significant Director-level leadership.
• Deep knowledge of global GCP requirements, ICH E6, FDA regulations, EU Clinical Trials Regulation considerations, and inspection readiness.
• Experience with eTMF, clinical quality systems, electronic GxP systems, 21 CFR Part 11, data integrity, and Veeva or similar platforms.
• Demonstrated experience managing GCP audits, regulatory inspections, CROs, clinical vendors, investigator sites, CAPA, and outsourced or hybrid development models.
• Experience with late-stage, pivotal, or registrational trials, risk-based quality management, quality metrics, and scaling QA in growing biotechnology organizations.

Nice to have

• Advanced scientific or related degree.
• At least three years of people management experience.
• Experience with Veeva or similar clinical technology platforms.

Culture & Benefits

• Hybrid work arrangement with flexible scheduling based on business needs.
• Health and wellness coverage tailored to the hiring country or region.
• Paid time off, public holidays, and additional leave in accordance with local requirements.
• Opportunity to contribute to patient safety, data integrity, compliance, and continuous improvement in a clinical-stage biotechnology environment.