Key skills
RLeadershipMentoring
About this role
Role Overview
- Strengthen and advance Amgen's R&D Quality Management System (QMS) and Safety & Medical Quality (SMQ) competencies
- Lead Safety and Medical Quality processes with focus on labelling and regulatory affairs activities
- Responsible for leading processes related to pharmacovigilance (GPvP) annual audit plan, preparation and execution of audits, and monitoring of Quality events
- Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality
- Assess and manage risks, including providing input into the annual GPvP audit plan
- Prepare, analyze, and communicate compliance metrics and other significant compliance information
- Maintain knowledge of current regulatory and compliance practices/issues and advise customers
- Develop long-term remediations and process improvements through Root Cause Analysis (RCA)
- Improve R&D processes by contributing expertise in identifying robust Corrective and Preventive Action plans (CAPA) and Effectiveness Verifications
Requirements
- Degree educated
- Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
- Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
- Previous experience supporting regulatory authority inspections of pharmacovigilance activities
- Experience of leading and/or supporting process improvement initiatives
- Previous leadership or mentoring experience is ideal
Benefits
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits