Quality Assurance Manager
AbbVie
August 12, 2026
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Operations
The Quality Assurance Manager provides quality assurance support for pharmaceutical products, medical devices, cosmetics, combination products, and biologics. Translates strategy into tactical objectives, ensuring product/process/system quality activities from raw material inspection through shipment comply with corporate and governmental regulations. Supports areas including Document Center, Device QA, Labeling, Validation, Training, Quality Intelligence, compendia management, and CAPA.
Responsibilities:
- Provide direction to professional staff (hiring, performance expectations/feedback, development).
- Develop Quality policies meeting regulatory and company requirements.
- Maintain expertise on regulations (FDA, EMA, ICH, etc.).
- Provide compliance leadership to the manufacturing site.
- Interface with FDA and other regulatory agencies and customers during inspections.
- Assess process/regulatory compliance to identify gaps and implement improvements in the quality system.
- Review/approve deviation investigations; drive reduction in quality events through robust CAPA.
- Compile, analyze, and communicate quality/compliance metrics to senior management.
- Establish programs to promote quality awareness and compliance.
Qualifications:
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area (preferred).
- 8+ years’ experience in quality assurance/oversight or relevant experience.
- Leadership experience with technical professionals and cross-functional teams.
- Knowledge in Quality, Regulatory, Process Sciences, and Manufacturing Operations.
- Familiarity with products, processes, equipment, and facilities for pharmaceutical/biological/device-related products.
- Knowledge of QA systems and GMP compliance requirements.
- Experience working both independently and in teams; manage time effectively.
- Strong oral and written communication skills.
- Excellent interpersonal skills (plus).
- Ability to lead medium to larger projects of increasing complexity.
Responsibilities:
- Provide direction to professional staff (hiring, performance expectations/feedback, development).
- Develop Quality policies meeting regulatory and company requirements.
- Maintain expertise on regulations (FDA, EMA, ICH, etc.).
- Provide compliance leadership to the manufacturing site.
- Interface with FDA and other regulatory agencies and customers during inspections.
- Assess process/regulatory compliance to identify gaps and implement improvements in the quality system.
- Review/approve deviation investigations; drive reduction in quality events through robust CAPA.
- Compile, analyze, and communicate quality/compliance metrics to senior management.
- Establish programs to promote quality awareness and compliance.
Qualifications:
- Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area (preferred).
- 8+ years’ experience in quality assurance/oversight or relevant experience.
- Leadership experience with technical professionals and cross-functional teams.
- Knowledge in Quality, Regulatory, Process Sciences, and Manufacturing Operations.
- Familiarity with products, processes, equipment, and facilities for pharmaceutical/biological/device-related products.
- Knowledge of QA systems and GMP compliance requirements.
- Experience working both independently and in teams; manage time effectively.
- Strong oral and written communication skills.
- Excellent interpersonal skills (plus).
- Ability to lead medium to larger projects of increasing complexity.