薬事品質保証部ディレクター〔総括ポジションン〕~定年62歳の優良企業~

Job Details

<求人タイトル>

17656 薬事品質保証部ディレクター〔総括ポジションン〕~定年62歳の優良企業~

<職務内容>

1. Responsible for quality systems and regulatory compliance to ensure process and product conformance to Japan regulations and the company requirements.
2. Responsible for maintaining and/or enhancing existing Quality functional systems in compliance with MHLW Ordinance requirements including but not limited to Ordinance 87, 94, 135, 169 in a manner that effectively supports growth for the company.
3. Responsible to coordinate and maintain product approvals, reimbursement registration, and business licenses in Japan on a timely manner.
4. Provides leadership and consulting services related to Japan regulations including Japanese Pharmaceutical Affairs Law and different MHLW ordinances; as well as assist during audits from Japanese government to the company’s manufacturing facilities and the Japan offices.
5. Responsible to maintain proper and timely communication with Japan regulatory authorities and notified bodies as needed; as well as to provide adequate information of the products as required by the regulatory offices.
6. Responsible to communicate to the Global in a timely manner of any potential product quality issues informed to the Japan office and coordinate with other QARA team members adequate investigations and corrective actions.
7. Responsible to coordinate with the Regulatory Affairs team of the Global any potential field action activity involved in the Japanese market for the Japan products.
8. As a key contributor to the Health Care organization, the incumbent is expected to understand the company’s business needs and serve as a key link between Japan and the Global offices and the business teams, suppliers and contract manufacturers impacting Japan market.
9. 部下2名をマネジメントいただきます。

<応募要件>

・A broad technical background, preferably a graduate level degree, or as a minimum, a bachelor’s degree in a science or engineering discipline, plus ten or more years of managerial experience in Quality or Regulatory Affairs as well as experience in establishing and managing compliance programs for medical devices and/or pharmaceuticals in the Japanese market.
・Experience should include close working relationships with Business, Marketing, Manufacturing and Research functions, and an in-depth knowledge and application of relevant domestic and international regulations.
・General knowledge of Regulatory requirements as:
・Japan Pharmaceutical Affairs Law
・Several MHLW Ordinances (i.e. 87, 94, 135, 136, 169)
・USA Regulations (21 Code of Federal Regulation, FDA Guidelines, QSIT, etc.)
・European Regulation (ISO 9001, ISO 13485, ISO 14971, and others)
・General knowledge in contamination control practices for the Japanese market
・Statistical Sampling
・Root Cause analysis and failure investigation tools
・Bilingual: English/Japanese

<会社概要>

世界約11ヵ国に製造拠点を置き、12,000人以上の従業員を擁する外資系医療機器メーカーです。主にサージカル用品等を開発・販売しています。

就業時間:9 時00 分~17 時45 分 ※フレックス制度あり

<注目ポイント>

APACもしくは直接グローバル本社のQARA責任者へのレポートとなり、インターナショナルな環境でご活躍いただける総括ポジションです。落ち着いたカルチャーでグローバルとの関係性も良好です。定年62歳というのも魅力の一つです。マネジメント経験をお持ちの方を募集しておりますので、ご興味がございましたら是非お気軽にお問い合わせください。

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