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[Consumer] Business Quality Director, North East Asia Cluster
Requisition ID: 1805649561W
& 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: Business Quality Director, North East Asia Cluster
2. Sector: 존슨앤드존슨 컨슈머 (Consumer)
3. Location: 서울시 용산구
The BQ Director has the overall Quality oversight & responsibility for the North-East Asia country cluster (Japan, Korea, Hong Kong & Taiwan) Consumer business, ensuring quality and compliance during the entire life cycle of all commercialized products. She/he needs to ensure compliance to the applicable regulations as well as company policies, standards & procedures.
1) Lead the effective implementation of the Quality Management system for Consumer businesses in Japan, Korea, Taiwan & Hong Kong. Ensure ongoing compliance to local regulations of all J&J products marketed by Consumer Local Operating Companies (LOC) in Japan, Korea, Taiwan & Hong Kong.
2) Be the Primary Quality partner for the business /commercial organizations. Partner with cross functional teams internally to ensure compliance of all products with local regulations at all times.
3) Continuously monitor and improve quality systems & procedures to ensure full compliance to Quality Policy, Enterprise standards, Worldwide Procedures and Guidelines. Participate in the global/regional reviews to ensure applicability for LOC execution, proper gap assessment and mitigation plan execution.
4) Lead Quality Systems Management review for LOCs, Product review, Quality Review Board, Product discontinuations and Field Actions for the LOCs. Partners with various functions within North East Asia and Asia Pacific (North East Asia Leadership Team, Supply Chain, Regulatory Affairs, R&D, Product Development, Marketing, CD, CLS among others) to meet business objectives.
5) Ensure implementation of the end-to-end complaints vigilance process. Lead the periodic review of complaints & adverse events with the appropriate local and regional stakeholders as defined in the QMS, and track needed actions to address adverse trends.
6) Lead preparedness of LOCs for regulatory inspections/audits, issue resolutions with Local Authorities and company management. Lead investigations, corrective and preventive actions for issues detected potentially affecting the products or to improve compliance with regulations. Keep country management aware of Quality and Compliance related issues/systems through periodic Management Review Process and issue escalation.
7) Manage and develop a capable organization. Be responsible for budget, staffing, career planning, training & development and providing for a safe & pleasant working environment for all quality employees. Ensure acceptable behavior and performance by the Quality team.
8) Provide leadership and guidance to cross-segment (Consumer and Medical Device) Business Quality in Hong Kong and Taiwan to ensure successful deployment of cross-segment leverage model.
1) Graduate or Post-graduate degree in Science, preferably in Pharmaceutical Sciences, Chemistry or Pharmacy. Additionally, a Management degree/diploma will be preferred.
2) Around 15 years of experience in the field of Quality Operations and Regulatory Compliance within the regulated pharmaceutical / Medical Device industry.
3) Comprehensive knowledge of North East Asian Regulations applicable to Drug, Quasi-drug, Cosmetic, & Medical Device products, for design, development, manufacture, supply & post-market surveillance.
4) Regulatory inspection experience is highly desirable.
5) Proven track record of leading the Quality & Compliance function of a Multinational Pharmaceutical/Cosmetic industry in a North East Asian country is highly desirable.
6) Track record of successful cross functional partnership and experience in managing virtual teams in a highly matrixed environment.
7) Superior written and verbal communication skills in English, besides language proficiency in at least one of the local languages spoken in North East Asia (Japan, Korea, Taiwan, Hong Kong).
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ohnson & Johnson Korea Sales & Distribution LLC (7227)