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新規ビジネス_化粧品  Business Quality Senior Manager

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外資系大手医薬品メーカー 新規ビジネス_化粧品 Business Quality Senior Manager

募集要項

業務内容

Lead and drive effective implementation of the Quality Management System for the newly acquired business of dermo-cosmetic products in Japan. Partner with the cross functional Unification team to identify the Quality/Regulatory risks (if any) and then ensure timely & effective remediation/mitigation of the risks. Develop and deploy near-term and long-term mitigation plans for the Post Acquisition Assessment findings .

Ensure ongoing and robust compliance to Japan regulations of all products of Company Holdings. This includes ensuring adequacy & compliance of GQP & GMP responsibilities for all Ci:z Holdings products commercially distributed/sold in Japan.

Regularly monitor and improve the quality systems & procedures to ensure compliance to Company Quality Policy, Enterprise standards, Worldwide Procedures and Guidelines. Ensure periodic Quality Systems Management Review, Product reviews, Escalations, Product Assessment Meetings, Quality Review Board, Field Actions and Product Discontinuations for the Company Holdings product in Japan.

Support the LOC Leads of the ex-Japan markets globally in their preparedness for the regulatory inspections/audits of Company Holdings products, 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.

Be the Primary Quality contact for the business /commercial organizations and work with various functions within APAC to meet business objectives.


※はじめは全国出張が多いです。

求められる経験

EDUCATION: Graduate or Post-graduate degree in Science, preferably in Pharmaceutical or Cosmetic Sciences, Chemistry or Pharmacy. Additionally, a Management degree/diploma will be preferred.


EXPERIENCE:
Around 10 – 15 years of experience in the field of Quality Operations and Regulatory Compliance within the regulated pharmaceutical / Medical Device / Cosmetics Japanese industry.
Comprehensive knowledge of Japan Regulations applicable to Drug, Quasi-drug, Cosmetic, & Medical Device products, for design, development, manufacture, supply & post-market surveillance.
Regulatory inspection experience with PMDA is highly desirable.
Proven track record of Quality & Regulatory Compliance function in Multinational Pharmaceutical/ Cosmetic industry in Japan is highly desirable.
Track record of successful cross functional partnership and experience in working with virtual teams in a highly matrix environment.
Superior written & verbal communication skills in English, besides language proficiency in Japanese is a must.

語学力


ビジネスレベル

給与

年俸制
当社社内規定準じる

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

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この求人に応募

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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