Manager, Product Development Quality Assurance
AbbVie
August 20, 2026
Remote friendly (North Chicago, IL)
United States
$109,500 - $208,500 USD yearly
Operations
Job Description
This role supports AbbVie’s pipeline by enabling batch disposition activities and ensuring high-quality clinical supplies compliant with global regulatory requirements are delivered to patients.
Responsibilities
- Review and approve batch records and release batches or analytical records.
- Write/review/approve processes, procedures, and related documents.
- Lead/assist preparation and management of audits by regulatory agencies, customers, and R&D GxP Compliance.
- Review draft/final regulations for impact to R&D business and incorporate procedural changes as necessary.
- Provide routine area-specific management support (backup to manager for routine activities).
- Support daily product release activities as applicable.
- Drive consistency and continual process improvements in PDQA through assessment and compliance of regulations and industry practice.
- Write/review/approve exception reports, including high impact and complex ERs.
- Lead/participate on assigned project teams to support product development.
- Monitor effectiveness of processes and quality of project work; propose and execute quality/process improvements.
Qualifications
- Bachelor’s degree (typically life sciences: biology, chemistry, engineering) or equivalent experience.
- Master’s degree preferred (not required with commensurate experience).
- 6+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients/drug products, drug development, or related healthcare field (less with advanced degree).
- Supervisory/project management experience is a plus.
- Broad understanding of pharmaceutical manufacturing processes (chemical/biological), analytical sciences, and GMP requirements (D, EU, US) preferred.
- Ability to defend the quality position and solve complex technical/quality issues.
This role supports AbbVie’s pipeline by enabling batch disposition activities and ensuring high-quality clinical supplies compliant with global regulatory requirements are delivered to patients.
Responsibilities
- Review and approve batch records and release batches or analytical records.
- Write/review/approve processes, procedures, and related documents.
- Lead/assist preparation and management of audits by regulatory agencies, customers, and R&D GxP Compliance.
- Review draft/final regulations for impact to R&D business and incorporate procedural changes as necessary.
- Provide routine area-specific management support (backup to manager for routine activities).
- Support daily product release activities as applicable.
- Drive consistency and continual process improvements in PDQA through assessment and compliance of regulations and industry practice.
- Write/review/approve exception reports, including high impact and complex ERs.
- Lead/participate on assigned project teams to support product development.
- Monitor effectiveness of processes and quality of project work; propose and execute quality/process improvements.
Qualifications
- Bachelor’s degree (typically life sciences: biology, chemistry, engineering) or equivalent experience.
- Master’s degree preferred (not required with commensurate experience).
- 6+ years industry experience in Quality Assurance, production, testing of active pharmaceutical ingredients/drug products, drug development, or related healthcare field (less with advanced degree).
- Supervisory/project management experience is a plus.
- Broad understanding of pharmaceutical manufacturing processes (chemical/biological), analytical sciences, and GMP requirements (D, EU, US) preferred.
- Ability to defend the quality position and solve complex technical/quality issues.