グローバル環境で英語と日本語を活かせる · 外部製造管理における品質保証の中核を担える · ハイブリッド勤務制度 · グローバルプロジェクトへの参画機会 · ...

グローバル製薬企業の品質保証部門をリードする責任ある役割です。日本市場における品質戦略の中核を担います。 · 日本国内のCMOに対するGxP監督責任 · GMPおよびGQPに基づく外部製造業者の管理 · 日本薬事法、薬局方、社内品質指針に基づくコンプライアンスの確保 · CMCコンプライアンスの維持と当局対応 · 品質契約の管理と社内外関係者との連携 · 品質改善の機会の特定と実行 · グローバル品質プログラムの導入と維持 · チームの育成・指導・組織構築 · KPIの設定と報告、リスクマネジメントの実施 · デジタルツールを活用した業務改善 · ...

医薬品製造における品質の卓越性を推進 · 患者の安全を確保するグローバルチームの一員になる · ...

+Leads the identification, design, and implementation of quality assurance programs and initiatives to improve process efficiency. · ...

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. · Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is drive ...

· Supports the development and continuous improvement of business quality management practices and facilities. · Automotive electronic connector parts (connectors, cables) related new product development project quality technical work. · ...

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. · Lead the construction, ...

Assists with developing and implementing new quality methods and procedures. · ...

The job involves regulatory affairs and quality assurance work for biopharmaceuticals including applications, document creation, and coordination. · Responsibilities include pharmaceutical applications, authority interactions, CTD and FD document creation, new product introductio ...

The Quality Administrator will be responsible for performing various administrative tasks, including creating and managing files, handling complaints, and conducting investigations. They will also be responsible for creating and distributing daily reports, as well as managing and ...

This is a Manager, Medical Customer Care GMT Business Unit position at Alexion Japan. The job involves working with medical professionals and being the primary point of contact for Alexion. The role requires building good relationships with medical professionals, providing custom ...

The CMC RA Manager will lead and manage CMC regulatory activities, develop and implement CMC registration strategies, and support the development of the CMCRA team. The ideal candidate will have +10 years of practical experience with CMC-related roles, experience drafting and com ...

Lead and manage CMC regulatory activities including relevant cross-functional communication, providing guidance across the product lifecycle, and ensuring timely regulatory compliance with official guidelines. Develop and implement CMC registration strategies related to CTNs, NDA ...

We put the diversity of our employees as a source of richness for the fulfillment of this vocation. · 製造委託先との製品に関する連携、技術移管及び移管後の維持管理を含む · ...

This is a position that carries out the practical work related to quality assurance for our company's products. · • Review domestic complaint information and provide information and confirm analysis results with domestic and foreign manufacturers. · • We will provide quality info ...

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. · p苦情担当スペシャリスト · tough punishment specialist · safety management department member performing following duties: kakujou shori: customer complai ...

This role involves leading quality assurance programs and initiatives to improve process efficiency. · ...

We are seeking a RegulatoryAffairs Specialist to join our team at JohnsonandJohnson.The successful candidate will be responsible for maintainingand managing regulatory approvals for pharmaceutical products including surgical suturesand adhesives. · ...

+This role involves maintaining regulatory approvals for general surgery products including sutures and tissue adhesives. · +Promptly managing regulatory compliance activities across various regions. · Establishing strong relationships with key stakeholders within local authoriti ...

+ · The company seeks an experienced professional for its regulatory affairs team responsible for maintaining management of Japan general surgery field products including sutures tissue adhesives etc. ...

Internal Audit Manager to lead audit activities in Japan, focusing on US-SOX compliance. Develop and execute annual audit plans, including US-SOX compliance audits. Design and improve audit methodologies aligned with J-SOX where applicable. Evaluate and document internal controls ...