Job Description

 

■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

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■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。

 

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■職務内容

（雇入れ直後 / Immediately after hiring）

 

•    Ensure Pharmaceutical Quality System and supporting processes are in place and implemented across the site for compliance and license to operate.
•    Ensure compliance with our Quality standards, Safety Health and Environment requirements.
•    Has technical oversight and responsibility for the quality and GMP/GDP compliance approaches and outcomes into the operations business area. 
•    Direct quality initiatives and improvement program aimed at ensuring compliance, continuous improvement, enhancing commitment to quality and improving profitability.
•    Leading all internal and external inspection management.
•    Act as point of contact for regulatory bodies at site, dealing with and resolving the complex issues.
•    Be responsible for ensuring that the requirements and implications of all applicable external regulations are understood, the risks and opportunities are identified during assessment and communicated to the right stakeholders for information, advice and decision.
•    Be responsible for ensuring that we are involved with and influential in key external organizations and events that interact with the local agencies that oversee and regulate the pharmaceutical industry within Japan.
•    Proactively look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
•    Proactively work with Regional/Global Quality network to share good practices and learning. Lead significant local cross-functional initiatives and above site initiatives in the regional/global network.
•    Lead and provide guidance in the daily job of the team. Build and develop team and personnel capability. Optimize performance outcomes of direct reports and ensure high quality IDP review.
•    Build and develop strong Quality talent pipeline for site Quality function and wider network. effectively.

（変更の範囲 / Scope of change）

会社の定める業務/Business as defined by the company

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■応募要件

【経験/ Experience】

- 必須/ Mandatory

•    Substantial relevant experience in pharmaceutical quality, manufacturing or regulatory roles
•    Experience working within cross functional and global teams 
•    Track record of working with regulatory health authorities/ stakeholders/ government bodies / industry associations
•    Experience of establishing and sustaining regulatory compliance culture 

•    Extensive work experience and deep understanding of culture(s) in Japan market 
•    Familiarity with the regulations in Japan
•    Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
•    Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

- 歓迎/ Nice to have

•    Lived and worked outside of Japan
•    Experience within a complex manufacturing/supply site environment
•    Experience in GQP roles

【語学、スキル等/ Languages/Skills】

- 必須/ Mandatory

•    Fluent in Japanese and English
•    Bachelor’s degree and Licensed Pharmacist (Japan)
•    Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

- 歓迎/ Nice to have

•    Ability to work externally and represent us with external industry associations

•    Excellent knowledge of our policies, procedures and guidelines

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■想定年収

規定により優遇

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■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

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・応募＝企業への応募ではありません。

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