Lead, Significant Quality Events & CAPA (GCP)

Integrated Resources Inc.; Groton (CT); On-site; USD 85,000 - 120,000; Full time

Job summary

A premier staffing firm seeks a professional to lead the management of Significant Quality Events within DevOps. The role requires collaboration with compliance teams, effective project management, and extensive knowledge in quality and regulatory processes. Candidates should be adept in leading initiatives and engaging with diverse stakeholders.

Qualifications

• In-depth knowledge of quality audit, quality management, inspection readiness, compliance assessments.
• Experience leading global initiatives or project teams, understanding clinical trials.
• Strong influencing skills and ability to manage a demanding workload.

Responsibilities

• Collaborate with CTPQ/GCP Compliance Management within DevOps.
• Lead the Significant Quality Event team, managing investigations and documentation.
• Interact with diverse internal stakeholders and ensure timely delivery of actions.

Skills

Quality management

Communication

Project coordination

Stakeholder engagement

Root Cause Analysis

Education

Degree in drug development or business

Tools

Quality audit

Regulatory requirements

Job description

A premier staffing firm seeks a professional to lead the management of Significant Quality Events within DevOps. The role requires collaboration with compliance teams, effective project management, and extensive knowledge in quality and regulatory processes. Candidates should be adept in leading initiatives and engaging with diverse stakeholders.