Global GCP QA Leader — Strategy & Compliance

SmartRecruiters, Inc.; North Chicago (IL); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie seeks a Senior Manager of Clinical Quality Assurance to lead GCP quality activities across one or more clinical programs. You will develop the Comprehensive Quality Strategy, oversee audits, and ensure readiness for health authority submissions, driving proactive quality management in a matrix environment.

The role requires strong leadership, strategic planning, and deep knowledge of global regulatory expectations, with the ability to influence across Development Operations and partner

Qualifications

• Bachelor’s degree in a physical science, life science, nursing, pharmacy or equivalent experience.
• 5+ years of pharmaceutical industry experience in GCP quality assurance or regulatory affairs or clinical development or clinical operations.
• 1+ years of GCP QA auditing experience.
• Demonstrated leadership experience in motivating teams to anticipate and deliver strong operating results.
• Problem solving abilities required at both strategic and operational levels, ability to identify and resolve issues related to quality and compliance with global and local regulations.

Responsibilities

• Develop and manage timelines and deliverables for the RDQA Comprehensive Quality Strategy plan.
• Design and implement an audit program of internal and external compliance audits.
• Interpret and apply current governmental regulations to study protocols and activities.
• Prioritize activities to meet study and program objectives.
• Interact with Development Operations and supporting functions to ensure quality compliance across clinical development.
• Identify and mitigate clinical quality risks and escalate to management.

Skills

Leadership

Problem solving

Strategic planning

Cross-functional collaboration

Audit program management

Education

Bachelor’s degree in physical/life sciences or nursing/pharmacy

Job description

AbbVie seeks a Senior Manager of Clinical Quality Assurance to lead GCP quality activities across one or more clinical programs. You will develop the Comprehensive Quality Strategy, oversee audits, and ensure readiness for health authority submissions, driving proactive quality management in a matrix environment.

The role requires strong leadership, strategic planning, and deep knowledge of global regulatory expectations, with the ability to influence across Development Operations and partner