Senior GCP QA & Audit Lead

BioSpace; North Chicago (IL); On-site; USD 120,000 - 155,000; Full time

Job summary

AbbVie is seeking a Senior GCP Quality role to lead quality activities across one or more clinical programs, driving proactive management and ensuring regulatory compliance. You will influence the Comprehensive Quality Strategy, perform audits, and oversee health authority interactions as the primary program liaison.

The role requires a Bachelor’s degree in a physical or life science and 5+ years in GCP QA or related fields, with strong leadership, strategic planning, and global regulatory

Qualifications

• Bachelor's degree in a physical or life science, nursing, pharmacy or equivalent experience.
• 5+ years of pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development or clinical operations.
• Proven leadership experience and ability to drive results and meet expectations.
• Strong problem solving and issue-resolution skills across global regulatory environments.
• Strategic planning and cross-functional execution experience in clinical development.
• Understanding of global pharma regulatory environments and RDQA functions.
• Experience preparing and presenting key information to stakeholders.

Responsibilities

• Develop and manage timelines and deliverables for the RDQA Comprehensive Quality Strategy plan, including risk and issue management.
• Design an audit program with internal and external audits to ensure inspection readiness.
• Interpret and apply current governmental regulations and guidelines to study protocols and activities.
• Prioritize activities to meet study/program objectives.
• Interact with Development Operations to ensure quality compliance across clinical development; mitigate quality risks.
• Provide program leadership in quality across clinical development functions.

Skills

Leadership

Problem solving

Strategic planning

Cross-functional collaboration

Regulatory compliance

GCP QA

Project management

Education

Bachelor's degree in physical or life sciences

Job description

AbbVie is seeking a Senior GCP Quality role to lead quality activities across one or more clinical programs, driving proactive management and ensuring regulatory compliance. You will influence the Comprehensive Quality Strategy, perform audits, and oversee health authority interactions as the primary program liaison.

The role requires a Bachelor’s degree in a physical or life science and 5+ years in GCP QA or related fields, with strong leadership, strategic planning, and global regulatory