Laboratory Manager, Product Development QA
AbbVie
August 19, 2026
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Operations
Purpose:
Primarily responsible for leading Product Development QA from an analytical perspective in support of clinical supply release.
Responsibilities:
- Support CMC teams in resolving complex technical Analytical challenges through various phases of development
- Provide leadership and daily support to the Lab QA team
- Drive continuous process improvement within Product Development QA by updating/authoring policies, processes, procedures, and related documents
- Lead QA Analytical audit/inspection preparation activities and support audits/inspections as the QA SME
- Develop, maintain, and report key quality metrics to Management
- Lead for analytical testing batch release; coordinate and resolve issues
- Review and approve excipient, drug substance, and product specifications, including justification and revisions
- Write/review/approve exception reports, including high impact and complex ERs impacting multifunctional areas
- Approve Laboratory investigations
- Assess compliance to regulations and industry practice and implement applicable process changes
Qualifications:
- Bachelor’s degree or equivalent experience required (typically life sciences or engineering); Master’s preferred
- 6–8 years of experience in a related field, preferably with quality assurance and/or analytical sciences
- Strong understanding of Active Pharmaceutical Ingredients (API) and drug product GMP manufacturing as applied to laboratory operations
- Strong understanding of Quality Assurance principles and systems
- Strong understanding of US and international regulations for quality systems and compliance for investigational products
- Experience in project management, coordination, and planning of complex activities
- Collaborative, risk-based approach to problem solving
- Effective oral and written communication to clearly communicate quality position and actions needed to resolve issues
- Ability to present and justify quality requirements across all levels of management
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees
- Eligible to participate in long-term incentive programs
Primarily responsible for leading Product Development QA from an analytical perspective in support of clinical supply release.
Responsibilities:
- Support CMC teams in resolving complex technical Analytical challenges through various phases of development
- Provide leadership and daily support to the Lab QA team
- Drive continuous process improvement within Product Development QA by updating/authoring policies, processes, procedures, and related documents
- Lead QA Analytical audit/inspection preparation activities and support audits/inspections as the QA SME
- Develop, maintain, and report key quality metrics to Management
- Lead for analytical testing batch release; coordinate and resolve issues
- Review and approve excipient, drug substance, and product specifications, including justification and revisions
- Write/review/approve exception reports, including high impact and complex ERs impacting multifunctional areas
- Approve Laboratory investigations
- Assess compliance to regulations and industry practice and implement applicable process changes
Qualifications:
- Bachelor’s degree or equivalent experience required (typically life sciences or engineering); Master’s preferred
- 6–8 years of experience in a related field, preferably with quality assurance and/or analytical sciences
- Strong understanding of Active Pharmaceutical Ingredients (API) and drug product GMP manufacturing as applied to laboratory operations
- Strong understanding of Quality Assurance principles and systems
- Strong understanding of US and international regulations for quality systems and compliance for investigational products
- Experience in project management, coordination, and planning of complex activities
- Collaborative, risk-based approach to problem solving
- Effective oral and written communication to clearly communicate quality position and actions needed to resolve issues
- Ability to present and justify quality requirements across all levels of management
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees
- Eligible to participate in long-term incentive programs