Johnson & Johnson Careers
[Janssen] Sr. Business Quality Manager
Requisition ID: 1905720005W
1. Position: Sr. Business Quality Manager
2. Sector: 한국얀센 (Janssen)
3. Location: Yongsan, Seoul
- 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.
• 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
• 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
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Janssen Korea, Ltd. (7220)