Senior Manager, Combination Products & Medical Devices
AbbVie
August 25, 2026
On-site
North Chicago, IL
$124,500 - $236,500 USD yearly
Operations
The Senior Manager, Quality provides leadership and direction to the Quality Function within Operations and is responsible for implementing AbbVie Quality Systems, including Incoming Quality Assurance, Manufacturing Quality Assurance, Validation of product and processes, Quality Engineering, Quality Control, Training, Regulatory Compliance, Quality Planning, Product Quality, and strategic initiatives. Manages a budget and leads a team of quality professionals for compliance and quality oversight for the plant and/or strategic initiatives, maintaining high product quality while achieving efficiency.
Responsibilities:
- Own quality assurance and quality control for products produced at a large, high-volume, high-complexity plant (e.g., API, finished goods, biologics, packaging, device).
- Act as decision-making authority for site Quality and Regulatory compliance.
- Ensure products are manufactured in conformance with corporate and all applicable regulatory requirements.
- Manage, train, and supervise a team of quality professionals.
- Provide regulatory/technical guidance to plant departments; serve as SME for AbbVie plants.
- Communicate with executive leadership for Quality Management Review and Quality Initiatives.
- Develop and administer the annual operating budget for the Quality unit.
- Make quality decisions covering facility design, laboratory controls, and product specifications to meet cGMP, FDA, EU, DEA, and other regulatory requirements.
Qualifications:
- Bachelor’s degree (Physical/Life Sciences, Pharmacy, or Engineering); Master’s or PhD preferred.
- Certified Quality Engineer or formal training in quality engineering or statistics (preferred).
- 8+ years combined experience in Manufacturing, QA, QC, R&D in pharma/biologics/device/chemical.
- 4+ years supervisory/technical leadership.
- Knowledge of physical/chemical characteristics of products and raw materials.
- Familiarity with statistical quality systems, electronic document management, and laboratory information management.
- Familiar with quality policies, cGMP, and other regulatory requirements.
- Strong people management, communication, and judgment.
Benefits (if eligible): paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.
Responsibilities:
- Own quality assurance and quality control for products produced at a large, high-volume, high-complexity plant (e.g., API, finished goods, biologics, packaging, device).
- Act as decision-making authority for site Quality and Regulatory compliance.
- Ensure products are manufactured in conformance with corporate and all applicable regulatory requirements.
- Manage, train, and supervise a team of quality professionals.
- Provide regulatory/technical guidance to plant departments; serve as SME for AbbVie plants.
- Communicate with executive leadership for Quality Management Review and Quality Initiatives.
- Develop and administer the annual operating budget for the Quality unit.
- Make quality decisions covering facility design, laboratory controls, and product specifications to meet cGMP, FDA, EU, DEA, and other regulatory requirements.
Qualifications:
- Bachelor’s degree (Physical/Life Sciences, Pharmacy, or Engineering); Master’s or PhD preferred.
- Certified Quality Engineer or formal training in quality engineering or statistics (preferred).
- 8+ years combined experience in Manufacturing, QA, QC, R&D in pharma/biologics/device/chemical.
- 4+ years supervisory/technical leadership.
- Knowledge of physical/chemical characteristics of products and raw materials.
- Familiarity with statistical quality systems, electronic document management, and laboratory information management.
- Familiar with quality policies, cGMP, and other regulatory requirements.
- Strong people management, communication, and judgment.
Benefits (if eligible): paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k); eligible for long-term incentive programs.