Senior Product Quality Leader - Global QA & Compliance

AbbVie; North Chicago (IL); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Long-term incentives

Job summary

AbbVie is seeking a senior QA Operations leader to drive quality and regulatory compliance across product transfers and site optimization. You will coordinate with regulatory affairs, manage third-party manufacturers, and guide quality decisions for sterile, biologics, and device products.

The role requires 8+ years in QA/Operations, strong FDA experience, and a robust technical background in pharmaceutical sciences. A comprehensive benefits package accompanies this leadership position at AbbVie.

Qualifications

• Bachelor's Degree in Life Science, Engineering, or related field.
• Total experience: 8+ years with at least 3 in QA Operations Management; 5+ years in Operations/Regulatory/Dev.
• Strong knowledge of biological/pharmaceutical technologies and QA/QC principles.
• Experience with FDA/regulatory inspections and third-party manufacturers.

Responsibilities

• Lead quality and compliance for product transfers and site optimization.
• Develop global Product Quality Assurance strategy across pharma, biologics, device, and TPMs.
• Perform final quality release of manufactured product lots from third parties.
• Advise on quality/regulatory decisions for various product types including sterile and devices.
• Maintain relationships with third party manufacturers and AbbVie sites to align quality and resources.
• Communicate with external QA groups to balance quality risk and cost.
• Prepare audit plans and support inspections and approvals; manage CAPAs and trend investigations.
• Review annual product reviews/reports from third party manufacturers to ensure timely, accurate data.

Skills

Quality Assurance

Operations Management

Regulatory

Problem Solving

Education

Bachelor's Degree in Life Science/Engineering

Tools

GMP Training

LIMS

Job description

AbbVie is seeking a senior QA Operations leader to drive quality and regulatory compliance across product transfers and site optimization. You will coordinate with regulatory affairs, manage third-party manufacturers, and guide quality decisions for sterile, biologics, and device products.

The role requires 8+ years in QA/Operations, strong FDA experience, and a robust technical background in pharmaceutical sciences. A comprehensive benefits package accompanies this leadership position at AbbVie.