[Innovative Medicine] Sr. Manager, Quality System 2 Group (Fuji Plant)

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Quality Assurance

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

職務 概要 Position Summary :



* The Senior Manager of Quality provides quality and compliance leadership for manufacturing activities at the Fuji Site.

The role is responsible for ensuring GMP compliance, product quality, inspection readiness, quality system effectiveness, and operational excellence across manufacturing operations.



* The position provides strategic quality oversight for commercial and Advanced Therapy products manufactured at the site and partners closely with sourcing sites for shared products and supply continuity.

The role also collaborates extensively with Commercial Quality (GQP) and other cross-functional stakeholders to ensure robust quality decision-making, effective risk management, and uninterrupted product supply to patients .

法規制の順守に関する責任 R egulatory Compliance R esponsibilities :

The Quality Senior Manager complies with all applicable regulations, including the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices, GMP /GCTP requirements, Narcotics and Psychotropics Control Law, corporate standards, policies, and procedures.

The role ensures that all quality activities are performed in accordance with regulatory requirements and company expectations while maintaining patient safety, product quality, and data integrity.

主な職務及び責務 Major Job Dut i es and Responsibilities :

Quality Oversight



* Provide quality leadership and oversight for manufacturing operations at the Fuji Site.



* Support commercial and Advanced T...