Senior Manager, Safety, Medical & Regulatory Quality
AbbVie
September 02, 2026
Remote friendly (North Chicago, IL)
United States
$124,500 - $236,500 USD yearly
Medical Affairs
Responsibilities:
- Contribute to continuous compliance with global regulations, AbbVie policies/procedures, and regulatory preparedness for relevant Regulatory Authority inspections; support pharmacovigilance and safety inspections.
- Demonstrate AbbVie Ways of Working and Leadership Attributes; lead people and manage innovation.
- Fulfill expectations and goals; foster open, honest communication and continuous improvement.
- Support and execute a holistic quality assurance model for applicable GxP activities (internal and vendor), ensuring integration with interfacing GxPs and cross-functional alignment; influence timely responses to safety/RA/MA compliance issues and audit/inspection findings.
- Determine and evaluate GxP compliance risks and propose suitable mitigations.
- Support business process owners to integrate quality at all stages of process development.
- Participate in front and/or back-room Regulatory Authority inspection activities related to safety, RA, and MA.
- Serve as a consultation partner on worldwide safety, regulations, and corporate policies (especially CAPA and related Quality disciplines).
- Generate, analyze, and report compliance metrics; escalate issues timely for earliest resolution.
- Contribute to development/implementation of systems and processes supporting global QA strategies and an inclusive RDQA audit program.
- Drive change and efficiency via effective feedback and recommendations; model AbbVie behaviors.
Qualifications:
- Bachelor’s degree (preferably Biology, Nursing, Pharmacy, or other science-based).
- 5 years pharmaceutical industry experience in pharmacovigilance, regulatory affairs and/or quality assurance.
- 5 years Quality Assurance experience.
- Strong analytical skills; organize work logically and succinctly; collaborate with RDQA and external partners.
- Extensive knowledge of quality standards, worldwide regulatory requirements, and industry best practices for safety, RA, or MA.
- Flexibility to adapt, prioritize with minimal supervision, and operate in a fast-paced high-pressure environment.
- Project management, interpersonal, and communication skills with ability to influence; comfortable working independently or in teams.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.
- Contribute to continuous compliance with global regulations, AbbVie policies/procedures, and regulatory preparedness for relevant Regulatory Authority inspections; support pharmacovigilance and safety inspections.
- Demonstrate AbbVie Ways of Working and Leadership Attributes; lead people and manage innovation.
- Fulfill expectations and goals; foster open, honest communication and continuous improvement.
- Support and execute a holistic quality assurance model for applicable GxP activities (internal and vendor), ensuring integration with interfacing GxPs and cross-functional alignment; influence timely responses to safety/RA/MA compliance issues and audit/inspection findings.
- Determine and evaluate GxP compliance risks and propose suitable mitigations.
- Support business process owners to integrate quality at all stages of process development.
- Participate in front and/or back-room Regulatory Authority inspection activities related to safety, RA, and MA.
- Serve as a consultation partner on worldwide safety, regulations, and corporate policies (especially CAPA and related Quality disciplines).
- Generate, analyze, and report compliance metrics; escalate issues timely for earliest resolution.
- Contribute to development/implementation of systems and processes supporting global QA strategies and an inclusive RDQA audit program.
- Drive change and efficiency via effective feedback and recommendations; model AbbVie behaviors.
Qualifications:
- Bachelor’s degree (preferably Biology, Nursing, Pharmacy, or other science-based).
- 5 years pharmaceutical industry experience in pharmacovigilance, regulatory affairs and/or quality assurance.
- 5 years Quality Assurance experience.
- Strong analytical skills; organize work logically and succinctly; collaborate with RDQA and external partners.
- Extensive knowledge of quality standards, worldwide regulatory requirements, and industry best practices for safety, RA, or MA.
- Flexibility to adapt, prioritize with minimal supervision, and operate in a fast-paced high-pressure environment.
- Project management, interpersonal, and communication skills with ability to influence; comfortable working independently or in teams.
Benefits:
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees; eligible for long-term incentive programs.