Senior Quality Leader, Manufacturing & Compliance

AbbVie; Mettawa (IL); On-site; USD 125,000 - 237,000; Full time

Job summary

AbbVie in the United States seeks a Senior Manager of Quality to lead the Quality Function in Operations, ensuring cGMP compliance, regulatory alignment, and strategic quality initiatives. You will manage budgets, build a capable team, and act as SME across AbbVie plants, communicating with executives on Quality Management Reviews. This role demands strong leadership, governance, and technical excellence to safeguard product quality.

Qualifications

• Bachelor’s degree in Physical or Life Sciences, Pharmacy, or Engineering; advanced degree preferred.
• CQE or formal training in quality engineering or statistics preferred.
• 8+ years in manufacturing QA/QC/R&D in pharma/biologics, device or chemical industry.
• 4+ years of supervisory/technical leadership experience.
• Strong understanding of cGMP and regulatory requirements.
• Effective people management and communication skills.

Responsibilities

• Oversee QA/QC activities for high-volume plant with cross-technology capabilities.
• Serve as SME for quality and regulatory programs at the site.
• Ensure conformance to corporate quality requirements and regulatory standards.
• Lead a team of quality professionals, including training and oversight.
• Provide regulatory and technical guidance across departments; interact with leadership.
• Manage annual operating budget for the Quality Unit and strategic initiatives.

Skills

Quality leadership

Regulatory compliance

Statistical quality

People management

Communication skills

Education

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

Master’s degree or PhD preferred

Tools

Electronic document management

LIMS

Job description

AbbVie in the United States seeks a Senior Manager of Quality to lead the Quality Function in Operations, ensuring cGMP compliance, regulatory alignment, and strategic quality initiatives. You will manage budgets, build a capable team, and act as SME across AbbVie plants, communicating with executives on Quality Management Reviews. This role demands strong leadership, governance, and technical excellence to safeguard product quality.