Senior Product Quality Leader (Science)

Regulatory Jobs; North Chicago (IL); On-site; USD 120,000 - 160,000; Full time

Job summary

AbbVie in North Chicago, IL seeks an experienced Quality Assurance Operations Manager to lead quality activities across product transfers and compliance with FDA and other agencies. You will coordinate with internal teams and third-party manufacturers to ensure on-time delivery and regulatory readiness.

The role emphasizes strong analytical skills, cross-functional collaboration, and a track record in pharmaceutical quality systems, with emphasis on sterile, biologics, and device products.

Qualifications

• Bachelor's Degree in Life Science, Engineering, or a related technical field.
• Total of 8+ years experience: at least 3 years in Quality Assurance Operations Management; 5+ years in Operations, R&D, Regulatory or Consulting.
• Strong understanding of biological/pharmaceutical technologies (sterile, biologics, devices, APIs, etc.).
• Experience with FDA and other regulatory agency interactions and inspections.
• Familiarity with third-party external manufacturing.

Responsibilities

• Maintains primary quality lead for project activities and team members to ensure on-time quality deliverables.
• Participates in global Product Quality Assurance strategy for pharmaceuticals, biologics, devices, and TPM facilities.
• Performs final quality release of manufactured product lots.
• Provides recommendations on quality and regulatory conformance and elevates high-risk events.
• Interfaces with external manufacturers and AbbVie plants to identify quality concerns and allocate resources.
• Leads audit readiness and pre-approval inspections for third-party manufacturers to ensure regulatory approvals without delays.

Skills

Quality Assurance

Operations Management

Regulatory Interactions

Analytical Skills

Education

Bachelor's Degree

Job description

AbbVie in North Chicago, IL seeks an experienced Quality Assurance Operations Manager to lead quality activities across product transfers and compliance with FDA and other agencies. You will coordinate with internal teams and third-party manufacturers to ensure on-time delivery and regulatory readiness.

The role emphasizes strong analytical skills, cross-functional collaboration, and a track record in pharmaceutical quality systems, with emphasis on sterile, biologics, and device products.