Senior GCP QA Lead — Quality Strategy & Inspections

Regulatory Jobs; Chicago (IL); On-site; USD 140,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

401(k) plan

PTO

Job summary

AbbVie is seeking a Senior RDQA professional to lead GCP quality activities across one or more clinical programs. You will shape the Comprehensive Quality Strategy, coordinate internal and external audits, and ensure readiness for health authority submissions.

Work cross-functionally with Development Operations and other RDQA functions to mitigate quality risks and maintain program oversight. Location options include North Chicago, Irvine, South San Francisco, Worcester, Dublin, or Maidenhead.

Qualifications

• Bachelor’s degree in a physical or life science, nursing, pharmacy or equivalent experience required.
• 5+ years of pharmaceutical industry experience in GCP quality assurance, regulatory affairs, clinical development or clinical operations.
• Leadership experience motivating teams to deliver strong operating results and meet expectations.
• Ability to identify and resolve quality/compliance issues with global and local regulations.
• Strategic planning and cross-functional execution capabilities.

Responsibilities

• Develop and manage project timelines and deliverables for the RDQA Comprehensive Quality Strategy plan.
• Design and implement an audit program with internal/external audits and assessments.
• Interpret and apply current governmental regulations, guidelines, policies, and procedures to study protocols.
• Interact with Development Operations to ensure quality compliance across clinical development functions.
• Lead the integrated cross-functional and comprehensive quality strategy plan.

Skills

GCP QA

Regulatory affairs

Clinical development

Cross-functional leadership

Problem solving

Education

Bachelor’s degree in physical or life science

Job description

AbbVie is seeking a Senior RDQA professional to lead GCP quality activities across one or more clinical programs. You will shape the Comprehensive Quality Strategy, coordinate internal and external audits, and ensure readiness for health authority submissions.

Work cross-functionally with Development Operations and other RDQA functions to mitigate quality risks and maintain program oversight. Location options include North Chicago, Irvine, South San Francisco, Worcester, Dublin, or Maidenhead.