Regulatory authority inspections of pharmacovigilance activities
Amgen is seeking a Quality Compliance Senior Manager for Labelling & Regulatory Affairs to enhance their R&D Quality Management System. The role involves leading safety and medical quality processes, managing compliance and audits, and ensuring adherence to regulatory requirements
Job Summary
This role will lead Safety and Medical Quality processes with a focus on labelling and regulatory affairs activities.
You will join a globally established team with decision-making authority for Labelling and Regulatory Affairs.
Amgen offers vast opportunities to learn and move up and across our global organization and a diverse and inclusive community of belonging.
Matching Summary
Match Score: 85
Amgen is seeking a Quality Compliance Senior Manager for Labelling & Regulatory Affairs to enhance their R&D Quality Management System. The role involves leading safety and medical quality processes, managing compliance and audits, and ensuring adherence to regulatory requirements.
Skills & Requirements
Must-have
pharmacovigilance (GPvP) annual audit plan
Quality events investigation and monitoring
regulatory authority inspections of pharmacovigilance activities
international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
Nice-to-have
proactive identification of compliance issues
innovative and proactive quality oversight methodologies
leadership or mentoring experience
Key Requirements
Degree educated
Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices
Thorough knowledge of R&D processes and operations