Senior Manager, Safety, Medical & Regulatory Quality - Hybrid
Core
Provide independent quality oversight of safety, Regulatory Affairs, and Medical Affairs activities across AbbVie's R&D and non-R&D functions to ensure compliance with global regulations and support drug/device development.
Role type
Senior Manager, Quality Assurance (Safety/Regulatory/Medical)
Builds
Independent quality oversight systems for safety, RA, and MA activities; supports regulatory agency inspections and audit programs.
Domain
Pharmaceutical R&D, Pharmacovigilance, Regulatory Affairs, Quality Assurance
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk evaluation and mitigation, GxP compliance management, Regulatory inspection support, Cross-functional collaboration, Strategic quality planning, Process improvement, Data analysis and reporting, Change management, Vendor quality oversight, Stakeholder consultation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Ensure continuous compliance with global regulations and AbbVie policies; Support and execute holistic quality assurance models for GxP activities; Determine and evaluate risks impacting compliance and propose mitigations; Actively participate in Regulatory Authority inspection activities; Generate and report metrics to demonstrate compliance status; Contribute to the development of global QA strategies and audit programs.
Seniority
Senior Manager, hands-on leadership