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
Master's degree & 6 years of scientific experience
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
Problem Identification and Resolution