お仕事情報

お仕事情報

Compliance Sr. Manager – Auditor:SS-3486MY

  • 外資系企業
  • 女性が活躍
  • 管理職・マネジャー
  • 英語を活かす

世界最大の独立バイオテクノロジー企業と、内資系研究開発型グローバル製薬企業との合弁会社

求人コード SS-3486MY
募集職種 Compliance Sr. Manager – Auditor
職務内容 Job Description:
This is an exciting opportunity for a Compliance Senior Manager position within our Global Research and Development Quality, Compliance and Audit (QCA) team. It is a key QCA position for planning and participating in global audits of Amgen’s clinical trials, vendors, internal process and pharmacovigilance activities.
This position would be based in Tokyo and reporting into a QCA Compliance Director Japan.
The position requires approximately 40% travel in Japan, Asia and international audit Sites, and also supports regulatory inspections of clinical sites and our facilities in Japan and Asian countries.

Key responsibilities include:
For Global QCA
• Plan, conduct and report routine and directed compliance complex audits types with proficiency across a majority of audit types
• Follow-up on corrective actions until resolution
• Identify and communicate compliance risks to QCA management
• Host and/or play a lead role in regulatory authority inspections
• Participate as a QCA representative in due diligence assessments (acquisitions, in-licensing, evaluations)
• Lead QCA process improvement initiatives
• Author and contribute to the development of QCA cross functional controlled documents
• Provide coaching/ mentoring to staff and provide cross training for staff in area of expertise

For Japan and Asia
• Provide GCP and PV related advices to clinical functions at us and global QCA in terms of Japan GCP specific requirements and local regulatory requirements
• Provide supports and advices to Amgen affiliates in Asian countries when requested
• Provide prompt and appropriate advices to clinical and other R&D functions at AABP.
• Share up-to-date information on HA inspections and key changes to clinical development environment in Japan with AABP R&D and QCA.
応募要件 Basic Qualifications:
Doctorate degree & 2 years of scientific experience
OR
Master’s degree & 6 years of scientific experience
OR
Bachelor’s degree & 8 years of scientific experience
Preferred Qualifications:
• Bachelor’s degree in appropriate discipline (required) or equivalent experience
our Proprietary - Confidential

Experience:
• Minimum 5 years auditing experience in GCP/ PV
• Experience supporting regulatory authority inspections (mainly PMDA inspections and if applicable outside of Japan including China CFDA)
• International auditing experience (Asia and/or US & EU)
• Participation in process improvement initiatives
• Compliance program or project management
• Leadership or mentoring experience

Knowledge:
• Knowledge of regulations applicable to area of technical expertise
• General knowledge of clinical development and PV process and operations
• Knowledge of audit/compliance program design and audit methodology
• Knowledge of regulatory authority inspection processes (mainly PMDA inspections and if applicable outside of Japan including China CFDA)
• Thorough knowledge of PV and GCP (both Japan GCP and ICH GCP)
• General knowledge of pre-clinical, clinical development, and PV process and operations

Key Competencies:
• Sufficient English skill for speaking/ communicating for conducting audits outside of Japan, writing appropriate audit report and collaborating with global QCA members and other our personnel.
• Verbal and Written Communication
• Team Work
• Time Management
• Interpersonal Skills
• Results Oriented
• Analytical Skills
• Leadership Skills
• Mentoring Skills
• Team Leadership
• Motivation Skills
• Decision Making
• Problem Identification and Resolution
勤務地 東京
年収 1200万円~1500万円
最終学歴 理系大卒
推奨される資格要件 PhD、理系
その他

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