Johnson & Johnson Careers

[Janssen] Quality Manager (마약류관리 담당자)

Yongsan-gu, South Korea
Compliance


Job Description

Requisition ID: 1805701069W

Johnson & Johnson is the world's most comprehensive and broadly based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical, and medical devices and diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.


1. 
포지션: Quality Manager (마약류관리 담당자)

2. 계열사: 한국얀센(Janssen)

3. 근무지: 서울시 용산구

 

[Summary] 

- Responsible for overseeing, monitoring and coordinating all aspects of the controlled substance & listed chemical compliance and security effort for the end to end South Korea supply chain (JSC and CLS) and LOC; ensures that established controlled substance operational controls, security systems, processes and procedures are in continual compliance with federal and local laws; collaborates with internal stakeholders to successfully resolve compliance issues.

- He/she is also responsible 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 Business Quality Manual.


[Responsibilities]

1) Controlled Substance Compliance

- Serve as company liaison with the local government for all Controlled Substance Compliance related issues and perform proactive contact with the local regulatory agencies, resolving unusual issues, expediting permit requests, obtaining special permission and clarification of requirements. Ensure timely communication to the districts on any material losses or diversions. Lead field visits as needed.

- In coordination with CS Regulatory Compliance ensure the Janssen manufacturing site, Local Operating Company and CLS facilities are inspection ready for Global Controlled Substance Compliance audits and support external inspections by federal, state and local law enforcement as well as corporate inspections related to Controlled Substance and listed chemicals. Host Controlled Substance Compliance related to Audit and Inspections. 

- Develops, maintains and implements site regulatory programs and systems to ensure CS regulatory compliance for end to end supply in South Korea. Actively monitor and assure compliance with country specific requirements for the handling of CS and applicable global standards, global and local SOPs. 

- Responsible for ensuring site compliance training is performed for all employees at site level. This training includes developing strong CSC SMEs/coordinators in the JSC, LOC and CLS.

- Completes or ensure completion of required CS government reporting. Ensure government required data is collected, accurately completed and submitted per government deadlines Sales Reports, Yearend Inventory reports, Quota, Narcotic Information Management System, Incident report etc. 

- Inspect and audit material handling, manufacturing, storage and destruction activities and identify potential compliance gaps as well as drive process changes in order to increase security and compliance. Follow-up on corrective actions, track timely closure of CAPAs and investigations. 

- Oversee Inventory Accountability and Reconciliation for all controlled substances. Assure all on-hand controlled substance materials accountability in manufacturing, laboratories and external storage locations (CLS and GCO) are maintained and tracked through a readily retrievable inventory system. Document deviations and investigations through Trackwise.

- Assist in handling and processing of controlled substance Investigational Samples and return goods from customer. Ensure government approved disposal practices are in place.

- Ensure deviations, incidents regarding controlled drug are entered ETS TrackWise and ensure proper follow up is done on the corrective action.  

- Ensure timely compliance metric reporting. Provide and present input to quarterly management review. 

- Oversee coordination regarding the shipping and receiving of controlled substance products and materials, check that method of shipment meets customer satisfaction, government regulations and protect product quality.


2) Purchasing Control

- Perform qualification, monitoring, periodic on-site audit and off-site assessment of suppliers and distributors. Communicate with related functions, external suppliers and distributors for qualification and monitoring timely. Manage and document quality agreement between Janssen Korea and suppliers.

- Ensure to manage proper Approve Supplier list(ASL) and Approved Distributor List(ADL).   Ensure suppliers and distributors status, information and records in TrackWise ETS.


3) Complaint Handling

- Receive Product Quality Complaints(PQC) from internal/external channels, provide input into the complaint handling system for investigation. Communicate with the complainant for collection of product information, coordinate retrieval of field samples and product compensation.

- Ensure complaint intake are timely completed. Communicate with physician, customer and pharmacy association to provide appropriate and timely response. If needed, visit complainant to retrieve field sample and response investigation result. Manage call center for PQC call handling and reporting.

- Perform periodic PQC reconciliation with related functions and call center. Perform complaint trend analysis periodically and, if needed, escalate significant/critical complaint issues to management and supply chain for further review, discussion, and follow up

- Perform PQC trainings for internal employees and call center agents. Coordinate and document internal meetings for resolving significant/critical complaint issues.


4) Quality System

- Ensure appropriate change control procedures are followed. Monitor local change control status for timely closure and support issues related to TrackWise ETS. Perform training for users.

- Ensure appropriate Quality Issue(QI), Investigation, CAPA procedures are followed. Monitor QI/CAPA status for timely closure, and support issues related to TrackWise ETS. Perform training for users.

- Prepare quality metric data for QSMR and monthly review for complaint handling, change control, quality issue, CAPA, purchasing control. Keep related trackers up to date.

- Update and keep product list up to date. Achieve quality records in TruVault.

- Establish and revise LOC procedures in accordance with local GMP/GDP, BQM and J&J requirements for complaint handling, change control, quality issue, CAPA, purchasing control.

- Support internal audit and HA inspection for auditing and documentation

- Oversight End to End labeling and artwork process and support issues for the process

 

[Requirements]

- Bachelor’s Degree or equivalent education

- At least 8 years’ experience in the pharmaceutical, law enforcement, or supply chain with emphasis on controlled substance handling and compliance. 

- Hands-on experience in QA and TrackWise system is preferred 

- Excellent interpersonal and communication skills

- Problem solving & project management skills, clear thinker and ability to work across functions/groups

- Proficiency in written and oral English

- The selected candidate must be able to domestic and/or overseas travel 15% of his/her time

 

 

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Qualifications

Primary Location
South Korea-Seoul-Yongsan-gu-
Organization
Janssen Korea, Ltd. (7220)
Job Function
Compliance
Requisition ID
1805701069W