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:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Seoul, Korea, Republic of

Job Description:

Essential Job Duties and Responsibilities

• Responsible activities accompanied by imported product release and in-country testing.

• Responsible for the quality of, and meeting the applicable requirements for, the products that the LOC markets, or the products that it produces for other companies.

• Responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes.

Imported Product Management

 

• Maintain SOP/WI related to imported product management including in-country testing

• Document and review required paper set for product release in a timely manner so that products are delivered to customers and patients without delay.

Quality Systems

 

• Monitor and review Nonconformance and Change Control records related to in-country testing in collaboration with External Quality and Regulatory Affairs.

• Implement the Quality System via transposition of the requirements of the Commercial Quality Manual.

• Execute minimum requirements regarding lifecycle management of specification and test method to ensure regulatory compliance and business continuity as a representative of Market Authorization Holder.

 

Minimum Qualification

 

• Understanding for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GMP/GDP activities the LOC undertakes. In this role, he/she has defined authority and responsibility for ensuring that quality system and processes are implemented and maintained according to Commercial Quality Manual

• In-depth knowledge for the specification & test method relate with chemical & biological drug products

• Up-to-date knowledge of relevant pharmaceutical legislation and GxP including but not limited to GMP/GDP;

• Good understanding of quality management system and local regulation

• Fluent in English spoken and reading

• Strong conversation skills with different internal/external stakeholders

 

  

 Other requirements

 

• Excellent time management skills

• Conversation skills with different internal/external customers and stakeholders

 

#LI-Hybrid

Legal Entity

Innovative Medicine

Job Type

Fixed-term

Application Documents

Free-form resume AND cover letter is required (in Korean or English).

Application Deadline

Open until the position is filled.

Notes

• Preference will be given to individuals subject to national veterans’ benefits and persons with disabilities upon submission of relevant documents as per applicable laws.

• Only candidates who pass the resume screening will be notified individually. However, notifications may be delayed due to company circumstances.

• If any false information is found in the application documents, the hiring may be canceled even after the offer is confirmed, and future applications may be restricted.

• Submitted documents will not be returned and will be deleted upon request.

 

 

Required Skills:

 

 

Preferred Skills:

Coaching, Compliance Management, Continuous Improvement, Corrective and Preventive Action (CAPA), Data Analysis, Detail-Oriented, Developing Others, Goal Attainment, Inclusive Leadership, Internal Controls, Leadership, Process Control, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards