メディカル・バイオ - メディカルGQP・GMP・品質保証・品質管理
メディカル・バイオ - ＣＭＣ薬事

This position will be responsible for ensuring the implementation and maintenance of the processes required for the quality management system. in place to meet or exceed compliance with global policies and local regulatory requirements.

■休日：完全週休二日制, 土, 日, 祝日, 夏季休暇, 年末年始

Desired Education, Skills and Experience

B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
10+ years of leadership experience within Pharmaceutical Quality in the pharmaceutical Industry.
Exceptional understanding of GQP/GMP/QMS regulations, guidelines and compliance requirements.
Practical experience in the pharmaceutical industry in commercial quality, distribution, manufacturing or QC role(s) for drugs.
Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
Demonstrated ability to work independently with minimal supervision.
Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments and exceptional self-management ability.
Strong vendor management and oversight skills.
Business level English (Writing, Reading and Speaking)

■職種未経験者：不可