[Innovative Medicine] Supervisor, Quality System Group, Quality Operations Dept., Manufacturing and

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Shizuoka, Japan

Job Description:

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at https://www.jnj.com/.

職務概要 Position Summary:


* GMP/GCTPにおける品質システム、コンプライアンスの関わる業務を自ら実施し、また、グループスタッフが担当する業務の監督を行う。Perform tasks related to quality systems and compliance in GMP/GCTP, and supervise the tasks handled by the group staff.

法規制の順守に関する責任 Regulatory Compliance Responsibilities:


* 医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律、GMP/GCTP及びコーポレートポリシー、手順に従う。Comply with Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP/GCTP, all corporate policies and procedure.

主な職務及び主な責任 Major Job Duties and Responsibilities:


* 変更管理、逸脱管理、リスク管理活動、査察等への対応などのGMP/GCTP活動  / Manage GMP/GCTP activities such as Change control, deviation control, risk register and audit management.


* グループスタッフが担当するGMP/GCTP活動、業態管理などの 監督  / Supervise staffs’ GMP/GCTP activities and license management activities.


* トラブルシューティング、逸脱調査、エスカレーションの準備、スタッフのサポート / Trouble shooting and investigation of deviation, prepare escalation and support staff.


* スタッフのキャリア形成のサポート / Supporting individual career development.


* 新しい取り組みのリードもしくはサポート / Lead or support new initiatives.

職務の要件 Job Requirement

教育/経験 Education and Experiences:


* 薬学、理化学または生物学の学位を修了しているこ...