Senior Quality Leader – GMP Compliance & Strategy

AbbVie Inc.; Mettawa (IL); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Long-term incentive programs

Job summary

AbbVie Inc. seeks a Senior Manager, Quality to lead the Quality Function within Operations, ensuring cGMP compliance, regulatory alignment, and continuous improvement across the site.

The role directs QA, QC, and Quality Engineering, manages a budget, builds high-performing teams, and partners with regulatory, manufacturing, and product development to uphold product quality and patient safety.

Qualifications

• Bachelor’s degree in physical or life sciences, pharmacy, or engineering.
• 8+ years combined experience in Manufacturing, QA, QC, R&D in pharmaceutical, biologics, device or chemical industry.
• 4+ years supervisory/technical leadership experience.

Responsibilities

• Provide leadership and direction to the Quality Function within Operations.
• Ensure product manufactured at the plant meets cGMP, FDA, EU, DEA and other regulatory requirements.
• Directly responsible for organization, training and supervision of their functional area.
• Provide regulatory and technical guidance to all plant departments; act as SME for AbbVie plants.
• Communicate with executive level for Quality Management Review and initiatives.
• Develop and administer the annual operating budget for the Quality Unit.

Skills

Leadership

Quality Assurance

Regulatory Compliance

Budget Management

People Management

Communication Skills

Quality Systems

Education

Bachelor's degree in Physical or Life Sciences, Pharmacy, or Engineering

Master's degree or PhD preferred

Tools

LIMS

EDMS

Quality Management Systems

Job description

AbbVie Inc. seeks a Senior Manager, Quality to lead the Quality Function within Operations, ensuring cGMP compliance, regulatory alignment, and continuous improvement across the site.

The role directs QA, QC, and Quality Engineering, manages a budget, builds high-performing teams, and partners with regulatory, manufacturing, and product development to uphold product quality and patient safety.