Amgen Regional Compliance Director in Shanghai, China
Lead quality compliance and audit activities for Region
Primary QCAL&P contact for compliance for key Alliances and partnerships e.g. Amgen Astellas BioPharma KK (AABP) .
Provide compliance leadership and direct support for Amgen's R&D business interests in the region (including business partners). *Lead and oversee local regulatory inspections and response preparationProvide remote and if necessary direct support to prepare for inspections for Amgen and Amgen business partners as needed.Implement the global R&D quality, compliance, audit and L&P strategy and Quality Management System within the region.Provide expert regional input to the annual risk assessment for audit planningConduct / participate in regional audits as required.Provide expert advice on QA/ compliance/ quality management activities and trends within the region.Provide leadership and direction for compliance matters and HA inspection related action for the regionContribute R&D compliance input into vendor evaluations and due diligence activities within the region.*Lead interaction with local regulatory authorities on key compliance issues when necessary.
Preferred Role Qualifications , Experience & Knowledge
Required: Bachelor's degree in appropriate discipline or equivalent, e.g. Nursing qualificationPreferred: Advanced degree, e.g. Master's or Doctorate degree*Strong decision-making, conflict management and communication skills
Required7+ years of quality assurance experience in the pharmaceutical industry with emphasis on GCP or PV complianceExperience supporting inspections by JAPAC region health Experience working for global company with fluency in English language to allow effective international communicationsFluency in MandarinPreferred: Experience supporting regulatory authority inspections of research and development activitiesParticipation in process improvement initiatives*Experience working in the China and/or Japan market
Thorough knowledge and application of international requirements of GCP and PV.Understanding of drug development processesAudit/Compliance program design and audit methodologyExpertise in regulatory requirements for medicinal products.*Foundational understanding of broader regulatory requirements in JAPAC region