Associate Director, Clinical Study Quality Lead – Hybrid

Vertex Pharmaceuticals LLC; United States; Hybride; USD 161 000 - 241 000; Plein temps

Résumé du poste

Vertex Pharmaceuticals Inc. is seeking a highly experienced Clinical Study Quality Lead (SQL), Associate Director, to provide advanced quality assurance oversight across multiple clinical trial programs and vendors.

The role ensures compliance with GCP, regulatory standards, and Vertex policies, while developing and executing risk-based audit and quality plans. The SQL will lead inspection readiness activities, support CAPA development, and collaborate with functional areas to mitigate risks and

Qualifications

• In-depth knowledge of ICH-GCP guidelines and global regulations.
• Experience across phases of clinical trial development involving drugs and biologics.
• Understanding of Event Management processes, CAPA and Effectiveness Checks.
• Ability to translate partner needs into quality management strategies.
• Proficient in communicating with internal and external stakeholders.

Responsabilités

• Provides GCP quality compliance oversight for studies to protect participant safety and data integrity.
• Develops and implements quality risk management plans and measures.
• Partners with cross-functional teams to develop risk-based audit plans.
• Reviews audit reports and CAPA responses and tracks closure.
• Manages inspection preparedness strategies from planning to response.
• Mentors junior staff and supports management reviews on GCP activities.

Connaissances

GCP compliance

Quality oversight

Audit management

Risk management

Regulatory guidance

Formation

Bachelor’s degree in science or allied health

Outils

MS Word

MS Excel

MS PowerPoint

Smartsheet

Visio

Description du poste

Vertex Pharmaceuticals Inc. is seeking a highly experienced Clinical Study Quality Lead (SQL), Associate Director, to provide advanced quality assurance oversight across multiple clinical trial programs and vendors.

The role ensures compliance with GCP, regulatory standards, and Vertex policies, while developing and executing risk-based audit and quality plans. The SQL will lead inspection readiness activities, support CAPA development, and collaborate with functional areas to mitigate risks and