Senior QA Leader, Clinical Supply & Trials

AbbVie; North Chicago (IL); On-site; USD 150,000 - 210,000; Full time

Job summary

AbbVie in North Chicago, IL invites an experienced Senior Manager, Clinical Product Supply Quality Assurance to shape program strategy and ensure high-quality, compliant clinical supplies across drug substance, drug product, and finished product stages.

You will partner with R&D, CMC, and external partners to mitigate risks, oversee complex investigations, and guide due diligence and integration activities while maintaining development timelines and patient safety.

Qualifications

• 8+ years in QA, production, testing, or related field.
• Experience in pharmaceutical development and clinical product supply.
• Knowledge of GMP requirements and regulatory expectations (US/EU).
• Experience with due diligence, in-licensing, collaborations or M&A.

Responsibilities

• Provide strategic QA oversight for clinical development programs.
• Represent QA on CMC and cross-functional teams.
• Defend risk-based quality positions on technical matters.
• Lead identification and mitigation of quality and supply risks.
• Oversee quality assessments for due diligence and integrations.
• Collaborate to establish and maintain quality agreements with partners.

Skills

Quality Assurance

GMP manufacturing

Analytical testing

Regulatory compliance

Education

Bachelor’s degree in life sciences or related

Master’s degree preferred

Job description

AbbVie in North Chicago, IL invites an experienced Senior Manager, Clinical Product Supply Quality Assurance to shape program strategy and ensure high-quality, compliant clinical supplies across drug substance, drug product, and finished product stages.

You will partner with R&D, CMC, and external partners to mitigate risks, oversee complex investigations, and guide due diligence and integration activities while maintaining development timelines and patient safety.