Global Product Quality & Compliance Senior Manager

AbbVie; Illinois; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

AbbVie is seeking a senior professional to lead Quality Assurance Operations and drive regulatory compliance across AbbVie plants and third-party manufacturers. You will manage quality, risk, and product-release activities to ensure on-time delivery while meeting global standards.

The role requires significant QA/Operations leadership, experience with FDA interactions, and the ability to coordinate cross-functional teams to support product launches and investigations across multiple sites.

Qualifications

• Bachelor’s degree in Life Science, Engineering or related technical field.
• Minimum 8+ years in quality assurance/operations with leadership experience.
• Experience with FDA or other regulatory inspections and audits.
• Strong problem-solving, analytical, and communication skills.

Responsibilities

• Serve as primary quality lead for project activities and cross-functional teams.
• Develop and implement global Product Quality Assurance strategies for pharma/biologics devices.
• Perform final quality release of manufactured lots, including TPM products.
• Advise on quality, regulatory conformance and risk management decisions.
• Coordinate with third-party manufacturers and AbbVie plants to ensure compliance.
• Support audits, inspections, and regulatory readiness activities.

Skills

Quality Assurance

Operations Management

Regulatory Compliance

FDA Interactions

Team Leadership

Education

Bachelor’s Degree in Life Science or Engineering

Job description

AbbVie is seeking a senior professional to lead Quality Assurance Operations and drive regulatory compliance across AbbVie plants and third-party manufacturers. You will manage quality, risk, and product-release activities to ensure on-time delivery while meeting global standards.

The role requires significant QA/Operations leadership, experience with FDA interactions, and the ability to coordinate cross-functional teams to support product launches and investigations across multiple sites.