Senior GCP Quality Lead - Clinical Studies

Regulatory Jobs; Boston (MA); Hybrid; USD 161,000 - 241,000; Full time

Job summary

Vertex is seeking a Clinical Study Quality Lead (SQL), Associate Director, to oversee advanced quality assurance of clinical trial operations and vendors across disease areas. You will ensure adherence to GCP, develop audit/quality plans, and drive inspection preparedness while mitigating risks in real time.

This role may evolve to include line management responsibilities and requires strong collaboration with R&D Quality Leadership and senior stakeholders.

Qualifications

• Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience.
• Deep knowledge of ICH-GCP guidelines and global regulations.

Responsibilities

• Serve as a GCP subject matter expert for clinical study execution.
• Oversee risk-based quality compliance across studies to ensure participant safety and data integrity.
• Develop and execute quality risk management plans and CAPA programs.
• Lead inspection preparedness activities and participate in audit activities.
• Mentor junior SQLs and potentially manage staff.

Skills

GCP knowledge

Regulatory regulations

Risk management

Communication

Project coordination

MS Office

Quality oversight

Audits & CAPA

Education

Bachelor's degree in science/health

Tools

MS Word

MS Excel

MS PowerPoint

Smartsheet

Visio

Job description

Vertex is seeking a Clinical Study Quality Lead (SQL), Associate Director, to oversee advanced quality assurance of clinical trial operations and vendors across disease areas. You will ensure adherence to GCP, develop audit/quality plans, and drive inspection preparedness while mitigating risks in real time.

This role may evolve to include line management responsibilities and requires strong collaboration with R&D Quality Leadership and senior stakeholders.