Strategic Clinical Supply QA Lead

BioSpace; North Chicago (IL); Hybrid; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Senior Manager, Clinical Product Supply Quality Assurance to provide strategic quality leadership for the clinical development pipeline. The role ensures timely delivery of compliant clinical supplies while protecting patient safety and enabling development milestones.

Based in a hybrid setting across AbbVie locations (North Chicago, IL; Worcester, MA; Irvine, CA; San Francisco, CA), the candidate will lead cross-functional teams, manage risk, and influence senior R&D and CMC

Qualifications

• Bachelor's degree in life sciences, chemistry, biology, engineering, pharmaceutical sciences, or related discipline; Masters preferred but not required based on commensurate experience.
• 8+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients, drug products, drug development or related healthcare field.
• In-depth knowledge of global GMP requirements and regulatory expectations; experience with due diligence, in-licensing, collaborations, M&A, or tech transfers.

Responsibilities

• Provide strategic QA oversight for assigned clinical development programs, including quality strategy and risk management.
• Serve as senior QA representative on CMC and product development teams to enable progression of investigational products into clinical trials.
• Lead or defend quality positions across manufacturing, analytical testing, supply, and compliance matters with senior leadership.
• Support regulatory inspections and internal audits readiness and represent Quality during inspections and partner assessments.

Skills

Quality Assurance

GMP

Regulatory

Risk Management

Cross-functional

Leadership

Project Management

Clinical supply

Education

Bachelor's degree

Masters preferred

Job description

AbbVie is seeking a Senior Manager, Clinical Product Supply Quality Assurance to provide strategic quality leadership for the clinical development pipeline. The role ensures timely delivery of compliant clinical supplies while protecting patient safety and enabling development milestones.

Based in a hybrid setting across AbbVie locations (North Chicago, IL; Worcester, MA; Irvine, CA; San Francisco, CA), the candidate will lead cross-functional teams, manage risk, and influence senior R&D and CMC