Senior Clinical QA Lead: GCP & Inspections

Integrated Resources Inc.; New Haven (CT); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading company in drug development is seeking a Clinical Quality Assurance IV to ensure quality management across programs. The ideal candidate will have over 9 years of experience, skills in managing clinical quality, and a strong understanding of GCP. As part of a dedicated team, you will facilitate compliance, manage quality issues, and prepare for inspections, contributing to the success of clinical operations.

Qualifications

• Minimum 9 years of experience in pharmaceutical or biotechnology drug development.
• Experience managing clinical quality activities and knowledge of clinical operations is essential.
• Comprehensive knowledge of relevant regulations required.

Responsibilities

• Develop and implement quality management plans for assigned programs.
• Manage quality issues, including audit reports and CAPA development.
• Lead inspection readiness and preparation activities.

Skills

Clinical Quality Management

Risk Management

Root Cause Analysis

GCP Compliance

Education

Bachelor's Degree

Master's Degree

Job description

A leading company in drug development is seeking a Clinical Quality Assurance IV to ensure quality management across programs. The ideal candidate will have over 9 years of experience, skills in managing clinical quality, and a strong understanding of GCP. As part of a dedicated team, you will facilitate compliance, manage quality issues, and prepare for inspections, contributing to the success of clinical operations.