[Innovative Medicine] Senior Supervisor, Quality System 2 Group, Quality Operations Dept., Manufactu

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:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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


* 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。


* 逸脱プロセスオーナーとして、逸脱全般を監督するとともに、個々の逸脱の評価・調査内容とCAPAの適格性を確認し、承認する。


* GMP査察等に対応し、指摘事項に関する継続的な改善をチームの一員として積極的に行う。


* 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を行う。


* チームメンバーとのコミュニケーションを活発に行い、個々の能力開発計画およびキャリア形成をサポートする。


* 継続的な改善のための新しい取り組みをサポートする。


* 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


* スタッフのキャリア形成のサポート


* 新しい取り組みのリードもしくはサポート



* Execute quality systems and compliance-related activities in GMP/GCTP, and oversee the tasks handled by group staff.


* Act as the deviation process owner, supervising all deviations, evaluating and investigating each deviation, and reviewing and approving CAPA for appropriateness.


* Manage GMP inspections and other audits, actively participating as a team member to implement continuous improvements based on audit findings.


* Supervise GMP/GCTP activities and operational management tasks performed by group staff.


* Maintain active communication with team members, supporting individual capability development plans and career growth.


* Support new initiatives aimed at cont...