Senior Clinical Study Quality Lead – GCP & Inspections

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

Benefits offered by this job

Annual bonus

Equity awards

401(k)

Commuting subsidy

Paid time off

Student loan repayment

Job summary

Vertex Pharmaceuticals Incorporated is seeking a Clinical Study Quality Lead (SQL), Associate Director to oversee advanced QA of clinical trial operations and vendors across study phases. The role ensures trials meet GCP, protocol, and Vertex Quality System standards, with development of audit/quality plans and real-time inspection readiness.

This position may evolve to include line management responsibilities and requires strong risk management, regulatory knowledge, and cross-functional

Qualifications

• In-depth knowledge of ICH-GCP guidelines and global regulations for clinical development.
• Experience across phases of clinical trial development with drugs and biologics.
• Understanding of Event Management, CAPA plans and effectiveness checks.
• Ability to translate partner needs into risk-based quality management approaches.
• Proficient in MS Office and quality metrics monitoring.

Responsibilities

• Serves as key technical resource and GCP subject matter expert to clinical study execution functions.
• Provides strategic, risk-based GCP quality oversight to drive regulatory compliance and data integrity.
• Consults on regulations, standards, and quality systems to study teams.
• Partners with study teams to implement proactive quality management and risk mitigation.
• Identifies and communicates quality risks; develops and implements risk-based plans.
• Develops audit plans for programs and reviews audit reports and CAPA responses.
• Creates inspection preparedness strategies and participates in inspections.
• Oversees quality events investigations and CAPA approvals.

Skills

GCP knowledge

Regulatory guidance

Risk management

Quality assurance

Vendor management

Audit planning

Root cause analysis

Communication

Education

Bachelor's degree in a scientific or allied health field

Job description

Vertex Pharmaceuticals Incorporated is seeking a Clinical Study Quality Lead (SQL), Associate Director to oversee advanced QA of clinical trial operations and vendors across study phases. The role ensures trials meet GCP, protocol, and Vertex Quality System standards, with development of audit/quality plans and real-time inspection readiness.

This position may evolve to include line management responsibilities and requires strong risk management, regulatory knowledge, and cross-functional