[Innovative Medicine] Senior Quality Specialist

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:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Seoul, Korea, Republic of

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

Position Summary
Established and productive individual contributor, who works under moderate supervision.

Supports the execution of tasks related to fulfilling the quality and regulatory requirements and established standards and customer needs for the organization's products, processes, and services.

Implements strategy and vision of continuous improvement and feedback through assessments and reporting.

Develops close partnership with all marketing companies functions and external business partner to identify risks and improvement opportunities and enhance the customer experience.

Essential Job Duties and Responsibilities

[Quality Systems]



* Ensure appropriate change control procedures are followed.

Monitor change control status for timely closure and support issues related to COMET.


* Ensure appropriate quality event management procedures are followed.

Monitor QEM status for timely closure and support issues related to COMET.


* Prepare quality metric data for QSMR and monthly review for change control and purchasing control.

Keep related trackers up to date.


* Update and keep product list up to date on TruVault.


* Establish and revise LOC procedures in accordance with local GxP, CQM and J&J requirements for change control.


* Support internal audit and HA inspection for auditing and documentation Support supplier qualification and document management.

[Quality Process]



* Manage the management of QA activities for imported products release from End to End, incoming inspection, sample shipment arrang...