Senior Clinical Study Quality Lead - Hybrid

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 144,000 - 241,000; Full time

Benefits offered by this job

Hybrid-Eligible

On-Site Eligible

Job summary

Vertex Pharmaceuticals LLC seeks an Associate Director, Clinical Study Quality Lead (Hybrid) to provide strategic GCP quality oversight across clinical trials and vendors. You will develop audit plans, ensure regulatory compliance, and drive inspection readiness while collaborating with cross-functional teams.

The role requires a strong background in ICH-GCP guidelines, risk management, CAPA processes, and vendor oversight, with potential line management responsibilities in the future.

Qualifications

• Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience.
• In-depth knowledge of ICH-GCP guidelines and global regulations (FDA, EMA, MHRA).
• Experience across phases of clinical trial development involving drugs and biologics.

Responsibilities

• Provide strategic, risk-based GCP quality oversight of studies to drive regulatory compliance.
• Develop and execute audit/quality plans; review CAPA and effectiveness checks.
• Lead inspection preparedness strategies and participate in inspection activities.
• Mentor junior team members and, if needed, assume people management duties.

Skills

GCP knowledge

Quality management

Risk management

CAPA processes

Audit planning

Regulatory knowledge

Vendor oversight

Communication

Education

Bachelor’s degree in a scientific or allied health field

Tools

MS Word

MS Excel

MS PowerPoint

Smartsheet

Visio

Job description

Vertex Pharmaceuticals LLC seeks an Associate Director, Clinical Study Quality Lead (Hybrid) to provide strategic GCP quality oversight across clinical trials and vendors. You will develop audit plans, ensure regulatory compliance, and drive inspection readiness while collaborating with cross-functional teams.

The role requires a strong background in ICH-GCP guidelines, risk management, CAPA processes, and vendor oversight, with potential line management responsibilities in the future.