Senior Manager, Safety, Medical & Regulatory Quality
Core
Manage global Safety, Regulatory Affairs (RA), or Medical Affairs (MA) Quality Assurance teams to provide independent quality oversight of safety activities across AbbVie's R&D and non-R&D functions, ensuring compliance with global regulations and supporting regulatory inspections.
Role type
Senior Manager, Quality Assurance (Safety/RA/MA)
Builds
Independent quality oversight systems for safety, RA, and MA activities; compliant drug/device/cosmetic development programs.
Domain
Pharmaceutical industry, Regulatory Affairs, Pharmacovigilance, Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP standards knowledge, regulatory compliance management, risk evaluation and mitigation, audit/inspection support, cross-functional collaboration, project management, data analysis and reporting, change management
Preferred skills
Experience in pharmacovigilance, regulatory affairs, or quality assurance within the pharmaceutical industry
Technologies
GxP frameworks, regulatory databases, quality management systems
Responsibilities
Ensure continuous compliance with global regulations and AbbVie policies; support Regulatory Authority inspections; evaluate risks impacting GxP compliance and propose mitigations; integrate quality into process development; generate and report compliance metrics; drive efficiency and organizational goals through feedback and recommendations.
Seniority
Senior Manager, hands-on leadership
