Amgen Compliance Sr. Manager - Auditor in Tokyo, Japan

This is an exciting opportunity for a Compliance Senior Manager position within Amgen's 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 Amgen 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 AABP 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.

Basic Qualifications:- Education -

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)Bachelor's degree in appropriate discipline (required) or equivalent experience

  • 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 Amgen Inc. personnel.

  • Verbal and Written Communication in English/Japanese

  • Team Work

  • Time Management

  • Interpersonal Skills

  • Results Oriented

  • Analytical Skills

  • Leadership Skills

  • Mentoring Skills

  • Team Leadership

  • Motivation Skills

  • Decision Making

  • Problem Identification and Resolution