Senior GCP QA Leader: Quality Strategy & Audits

BioSpace; North Chicago (IL); On-site; USD 120,000 - 190,000; Full time

Job summary

AbbVie is seeking a senior GCP quality professional to lead and manage the Comprehensive Quality Strategy for multiple clinical programs. You will influence audits, inspections, and cross-functional quality activities across R&D to ensure market-ready data and regulatory success.

Responsibilities include risk management, regulatory interpretation, and proactive quality leadership. Location options include North Chicago, Irvine, South San Francisco, Worcester, Dublin, or Maidenhead with a strong

Qualifications

• Bachelor's degree in a physical science, life science, nursing, pharmacy or equivalent.
• 5+ years of pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development, or clinical operations.

Responsibilities

• Lead the Comprehensive Quality Strategy plan and risk management for studies.
• Design and implement internal and external audit programs and assessments for inspection readiness.
• Interpret and apply current governmental regulations to study protocols and activities.
• Prioritize activities to meet study objectives and timelines.
• Partner across development operations to ensure quality compliance in all clinical development aspects.
• Provide cross-functional leadership and drive proactive quality management.
• Anticipate future business needs and shape the quality program road map.
• Act as primary quality liaison during health authority inspections.

Skills

GCP QA

Regulatory affairs

Clinical development

Problem solving

Strategic planning

Education

Bachelor's degree in physical or life science

Job description

AbbVie is seeking a senior GCP quality professional to lead and manage the Comprehensive Quality Strategy for multiple clinical programs. You will influence audits, inspections, and cross-functional quality activities across R&D to ensure market-ready data and regulatory success.

Responsibilities include risk management, regulatory interpretation, and proactive quality leadership. Location options include North Chicago, Irvine, South San Francisco, Worcester, Dublin, or Maidenhead with a strong