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ビジネスクオリティー North East Asia ディレクター

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外資系大手医薬品メーカー ビジネスクオリティー North East Asia ディレクター

募集要項

業務内容

[Position Summary]
The BQ Director will have the overall Quality oversight and responsibility to ensure Quality and Regulatory Compliance of all commercialized products in the North-East Asia country cluster (Japan, Korea, Hong Kong & Taiwan). She/he needs to ensure compliance to the applicable local regulations as well as to the company policies, standards & procedures, across the product lifecycle.
[Responsibilities]
・Lead the effective implementation and sustenance of the Quality Management system for Consumer Healthcare business in Japan, Korea, Taiwan & Hong Kong. Ensure ongoing compliance to the local regulations of all J&J products commercially sold/distributed by the Local Operating Companies (LOC) in Japan, Korea, Taiwan & Hong Kong.
・Be the Primary Quality partner for the business /commercial organizations. Collaborate cross functionally to ensure compliance of all products with local regulations at all times.
・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 its applicability for the LOC execution, proper gap assessment and mitigation plan execution.
・Lead Quality Systems Management review for the LOCs, Product reviews, Escalations, Quality Review Board, Product discontinuations and Field Actions for the LOCs. Partner with various functions within North East Asia cluster (North East Asia Leadership Team, Supply Chain, Regulatory Affairs, R&D, Marketing, Sales, Legal among others) to meet business objectives.
・Ensure implementation of the global 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.
・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 the Quality and Compliance related issues/systems through periodic Management Review Process and issue escalation.
・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.
・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.

求められる経験

■Education:
・Graduate or Post-graduate degree in Science, preferably in Pharmaceutical Sciences or Pharmacy. Additionally, a Management degree/diploma will be preferred.
■Experience:
・10 years experience in the field of Quality Operations and Regulatory Compliance in the regulated pharmaceutical / Medical Device industry. (number of years can be discussed within balance with the ability)
・Comprehensive knowledge of North East Asian Regulations applicable to Drug, Quasi-drug, Cosmetic, & Medical Device products, for design, development, manufacture, supply & post-market surveillance.
・Regulatory inspection experience is highly desirable.
・Proven track record of leading the Quality & Compliance function of a Multinational Pharmaceutical/Cosmetic industry in a North East Asian country is highly desirable.
・Track record of successful cross functional partnership and experience in managing virtual teams in a highly matrixed environment.
・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).


語学力


ビジネスレベル

給与

年俸制
※待遇 能力、経験を考慮の上、当社規定により優遇

雇用形態

正社員

勤務地

東京都

通勤交通費

全額支給

休日

土、日、祝日、会社規定
年間休日122日

福利厚生

各種社会保険完備

企業情報

事業内容

■総合医療・健康関連用品の輸入・製造販売

業種分類

医療機器、素材・化学・バイオ・医薬品
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