Senior Clinical Study Quality Lead (Hybrid)

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 161,000 - 241,000; Full time

Benefits offered by this job

Hybrid-Eligible

Job summary

Vertex Pharmaceuticals is seeking a Clinical Study Quality Lead (Associate Director) to provide advanced QA oversight of clinical trial operations and vendors across study phases. You will develop and execute audit/quality plans, manage CAPA, and drive inspection readiness with cross-functional teams.

This role may evolve to include people management and requires deep ICH-GCP knowledge, risk-based quality strategies, and strong collaboration with R&D Quality leadership.

Qualifications

• ICH-GCP guidelines knowledge and global regulatory awareness.
• Experience across phases of clinical development with drugs/biologics.
• Understanding of event management, CAPA and investigations.
• Ability to translate partner needs into risk-based quality approaches.
• Strong written and verbal communication for internal/external customers.
• Proven organizational, problem-solving and prioritization skills.

Responsibilities

• Serve as GCP SME for clinical study execution functions.
• Oversee risk-based GCP quality compliance across studies.
• Consult on regulations, standards, and quality systems.
• Develop risk-based quality and audit plans; review CAPA.
• Lead inspection preparedness and participate in inspections.
• Mentor SQLs; may assume people-management responsibilities.

Skills

GCP knowledge

Quality oversight

Risk management

Audit planning

CAPA management

Regulatory guidance

Communication

MS Office (Word, Excel, PowerPoint)

Smartsheet

Therapeutic area knowledge

Education

Bachelor’s degree in a scientific or allied health field

Tools

MS Word

MS Excel

MS PowerPoint

Smartsheet

Visio

Job description

Vertex Pharmaceuticals is seeking a Clinical Study Quality Lead (Associate Director) to provide advanced QA oversight of clinical trial operations and vendors across study phases. You will develop and execute audit/quality plans, manage CAPA, and drive inspection readiness with cross-functional teams.

This role may evolve to include people management and requires deep ICH-GCP knowledge, risk-based quality strategies, and strong collaboration with R&D Quality leadership.