QA Sr mgr or Associ Director

Company Overview
Global Pharmaceutical company

Job Description
 Responsible for maintaining and enhancement of Quality Management System
(QMS) with regulatory requirements and our company global standards.
 Responsible for providing guidance on interpretation and application in accordance
with relevant GQP&GMP&GDP regulations.
 Uses advanced statistical techniques for data analysis. Uses complex research
techniques and methodologies such as six sigma and kaizen to improve
process/product quality
 Independently initiates and develops new methods to facilitate management’s ability
to make strategic decisions.
 Develops a strong relationship with stakeholders including Supply Chain, Commercial
Operations, Corporate Quality, Customer Service, Regulatory, PV and Manufacturing
to ensure that product distribution processes are aligned to the regulatory
requirements and the needs of our company and its customers, ensuring best
practice, compliance and alignment with business needs.
 Responsible person for Product Quality Complaints
 Support any activities of Quality Head for Quality Management Review.
 Support any activities of Quality Assurance Manager (品質保証責任者) with
contributing to improvement and execution of All GQP/GDP activities including
deviation, change management, Quality information, GQP/GDP training, Batch
Record Review, CMO management, self-inspection and recall in our company Japan
end, as a deputy of Quality Assurance Manager
 Works on problems that are complex in scope where analysis of situations or data
requires in-depth evaluation of various factors. Determines corrective action on
investigative findings and with consideration of the long-term impact of decisions.

Requirements
 10+ years of QA relevant experience in the pharmaceutical industry and a Master of
Science.
 5+ years of QA relevant experience with Quality Management System
 Experience with Electronic Document Management Systems or other GXP
applications.
 Experience in Project Management for Launch, site transfer and analytical transfer.
 Experience in GMP compliance inspections, FMA and Conformity check.
 Experience in analytical, process chemistry and/or formulation development.
 Experience in Biologics and Cell Therapy is preferred.

日本東京 地図

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