Johnson & Johnson Careers

[Janssen] Sr. Business Quality Manager

Yongsan-gu, South Korea
Quality (Generalist)


Job Description

Requisition ID: 1905720005W

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. Position: Sr. Business Quality Manager 

2. Sector: 한국얀센 (Janssen)

3. Location: Yongsan, Seoul


[Summary]

- He/she is responsible for developing quality strategic plan and to assuring the integration/alignment of end-to-end quality strategy into the commercial quality strategy and process during NAVI transition.

- He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities the LOC undertakes including but not limited to GMP/GDP activities, in collaboration with end-to-end quality functions (R&D, CLS, and JSC). 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]

• Oversees the development and execution of end-to-end quality strategy and process during NAVI transition, by participating in end-to-end workstreams to ensure integration of quality into all post-HyangNam supply and release process, with an emphasis on prevention, continuous improvement, and customer satisfaction.

• Develops, drives budget, organizational structure, and business requirements to accommodate business needs 

• Assures appropriate processes and resources are in place and effective to deliver a sound compliance profile in commercial organizations for the current and future business needs for quality.

• Ensure the compliance of controlled substance related processes end-to-end for Korea, including JSC, CLS, R&D and LOC.

• Notify and engage LOC Quality Head and Business Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or compliance, as per the Escalation procedures

• Lead BQ staff through regular conversations and coaching to identify development need/opportunities and to provide proper support and motivation


[Requirements]

• Pharmacist preferred. Life sciences, Chemistry degree

• Minimum of 10-12 years of relevant regulated medical industry experience (pharmaceutical, medical device and/or diagnostics), ideally with a mix of Manufacturing / QA operations, Distribution Warehouse management, Regulatory Affairs, R&D and some commercial experiences.

• Hands- on experience in pharmaceutical product quality assurance


Sr BQ Manager should meet the following knowledge, experience and skills:

• Demonstrated ability to handle multiple projects with complexity

• Excellent interpersonal and communication skills – including proficiency in written and oral English

• Proactive team player, able to take charge and follow-through. 

• Achievement-oriented with a high degree of flexibility and ability to adapt to a changing regulatory environment & business needs. Leadership & decision making, self-motivated, clear thinker

• Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes

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

• Preferred: Knowledge and full understanding of the J&J Quality Policy, and the procedures and processes outlined in this Manual


[JD 확인 및 지원 방법]
http://www.careers.jnj.com -> Job number 1905720005W 검색 -> 해당 모집 공고 클릭 후, “Apply Now”

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Qualifications
-
Primary Location
South Korea-Seoul-Yongsan-gu-
Organization
Janssen Korea, Ltd. (7220)
Job Function
Quality (Generalist)
Requisition ID
1905720005W