職務内容
■働く魅力：Great Place to Work®に認定企業
・働きがいのある職場: Great Place to Work®に認定されており、社員が誇りを持って働ける企業文化が醸成されています。
・柔軟な働き方: コアタイムなしのフレックスタイム制度を導入しており、始業・終業時間を自由に調整できます。
・社員の成長支援: 「Learning for Life」プログラムを通じて、リーダーシップ研修やメンタリング制度など、継続的な学習機会を提供しています。・多様性とインクルージョン: LGBTQIA+の支援や障がい者雇用の推進など、多様なバックグラウンドを持つ社員が活躍できる環
___________________________
■企業の魅力：
・抗がん剤領域の強さ: 競合他社よりも積極的な新薬開発を進めており、特に免疫療法や分子標的治療に強みを持っています。
・日本市場での存在感: 日本国内の外資系製薬会社の売上ランキングでは、トップに位置しており、競合他社よりも市場での強い影響力を持っています。
・ 研究開発への投資: 年間数十億ドル規模の投資を行い、循環器・代謝疾患、呼吸器疾患などの重点領域で競争力を維持しています。
・ 戦略的提携: 他の製薬企業との提携を積極的に進め、特にオンコロジー領域での成長を加速させています。
境を整えています。
___________________________
■職務内容
（雇入れ直後 / Immediately after hiring）
• Leads Quality function in a manner that maximises its contribution to the achievement of business objectives, profitability and return on investment. May have direct contribution to achievement of objectives across our more broadly.
• Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit.
• Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
• Ensure continuing suitability and effectiveness of the quality management system, product quality and GMP/GDP compliance through management reviews and through advocating continuous improvement.
• Is responsible for ensuring that the requirements and implications of all applicable external regulations and our Quality Management System and Code of Ethics are understood and effective implementation processes are put in place in all parts of the business area for that is responsible for.
• Has technical oversight and responsibility for the quality and GMP/GDP compliance approaches and outcomes into the operations business area.
• Is responsible for ensuring the professional development of the organisation in order to provide sufficient qualified resources and strong succession pipeline for site quality function and wider network.
• Is responsible for ensuring that we are involved with and influential in key external organisations and events that interact with the government agencies that oversee and regulate the pharmaceutical development, manufacture and quality systems for medicines within Japan.
• Is responsible for the Management review process and outputs for the site and for ensuring appropriate management focus on quality and compliance topics affecting Japan Operations business.
• Leads the Quality elements of change programmes and projects in their site, working with the business to prioritise delivery of the Global Quality strategy.
• Optimises key relationships with organisations (e.g. external regulatory bodies and Quality networks) to take full advantage of efficiencies and meet compliance obligations.
• Works in partnership with the business and specialist Quality colleagues to ensure that an environment of continued professional development is created and individual and team performance is managed effectively.
（変更の範囲 / Scope of change）
会社の定める業務/Business as defined by the company
___________________________
■応募要件
＜必須 / Mandatory＞
'-Leadership of significant cross-functional change programmes/initiatives with Proven courageous leadership consistently challenging the status quo and promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives.
-At least 10 years’ experience in the pharmaceutical industry including at least 3 years’ experience in Clinical Development / Assurance / Advice
-Well-informed understanding of drug development process and related GCP activities and understanding of skills and knowledge required for successful delivery of a clinical trial, e.g. GCP, monitoring, data management, study drug delivery etc.
-Proficient knowledge of local and international regulations and guidelines
-Knowledge of Clinical Procedural Documents
＜歓迎 / Nice to have＞
-Process Management including developing / reviewing Procedural Documents in Japanese / English
-Professional excellence: Background of high professional achievement and willingness to encourage this in others
【資格 / License】
＜必須 / Mandatory＞
Bachelor’s degree (or equivalent), preferably in biological science or discipline associated with clinical research.
＜歓迎 / Nice to have＞
MBA, Project Management Professional(PMP)
【能力 / Skill-set】
＜必須 / Mandatory＞
-Leadership
-Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills in a multicultural environment
-Integrity and high ethical standards
-Manages change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business.
-Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
-Makes effective decisions despite uncertainty and/or incomplete information.
-Communicates clearly to ensure alignment and empowers others with decision-making authority as appropriate.
-Seeks diverse views and incorporates them where appropriate in order to develop better proposals and creative solutions for the business.
＜歓迎 / Nice to have＞
Consistently exhibits Leadership capability as below
- Commitment to Customers & Integrity; Focuses on What’s Important: Balances and prioritizes across diverse and competing customers, needs and opportunities.
- Demonstrates the courage to make tough and ethical decisions about where to devote resources.
【語学 / Language】
＜必須 / Mandatory＞
日本語 Japanese：Native Level
英語 English：Business English (Achieve common understanding at the context level with customers, and at monthly global meetings)
___________________________
■想定年収
規定により優遇
___________________________
■勤務地
（雇入れ直後 / Immediately after hiring）滋賀県、米原
（変更の範囲 / Scope of change）会社の定める場所
___________________________
・応募＝企業への応募ではありません。
・弊社との面談を希望される場合、この案件にお気軽にご登録ください。
・面談の際に、ご志向などをお聴きし、ご希望に応じた案件もご提案させていただきます。