Quality Assurance Manager
AbbVie
June 30, 2026
On-site
North Chicago, IL
$109,500 - $208,500 USD yearly
Operations
Job Description
The Quality Assurance Manager provides quality assurance support for manufacturing processes for pharmaceutical products, medical devices, cosmetics, combination products, and biologics. Supports strategic direction, translating strategy into tactical objectives, and ensures product/process/system quality activities comply with corporate and governmental regulations.
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/customers during inspections
- Perform compliance assessments to identify gaps and implement improvements within the quality system
- Review and approve deviation investigations; drive reduction in quality events through robust CAPA
- Compile, analyze, and communicate significant 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
- Technical knowledge in Quality, Regulatory, Process Sciences, Manufacturing Operations
- Knowledge of GMP compliance and regulations/standards affecting device, biologics, and pharmaceutical products
- Familiarity with product/process/equipment/facilities for pharmaceutical/biological/device-related products
- Experience working both independently and in teams; manage own time with manager guidance
- Strong oral (all management levels) and written communication skills; excellent interpersonal skills a plus
- Ability to lead medium to larger projects with increasing complexity
The Quality Assurance Manager provides quality assurance support for manufacturing processes for pharmaceutical products, medical devices, cosmetics, combination products, and biologics. Supports strategic direction, translating strategy into tactical objectives, and ensures product/process/system quality activities comply with corporate and governmental regulations.
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/customers during inspections
- Perform compliance assessments to identify gaps and implement improvements within the quality system
- Review and approve deviation investigations; drive reduction in quality events through robust CAPA
- Compile, analyze, and communicate significant 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
- Technical knowledge in Quality, Regulatory, Process Sciences, Manufacturing Operations
- Knowledge of GMP compliance and regulations/standards affecting device, biologics, and pharmaceutical products
- Familiarity with product/process/equipment/facilities for pharmaceutical/biological/device-related products
- Experience working both independently and in teams; manage own time with manager guidance
- Strong oral (all management levels) and written communication skills; excellent interpersonal skills a plus
- Ability to lead medium to larger projects with increasing complexity