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Manager, Safety & Quality Management Office

Employer
Bristol Myers Squibb
Location
Chiyoda-ku, Tokyo, Japan
Salary
Competitive
Start date
28 Nov 2023
Closing date
28 Dec 2023

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Discipline
Medical Affairs, Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Position Summary
  • Enhance Governance in regard with safety and quality in the Marketing Approval Holder, and ensure regulatory compliance, patient safety and stable product supply with high quality
  • Assist and support Chief Pharmaceutical Officer in contributing to BMSKK's business through stakeholder management and risk management.
  • Collaborate with Regulatory, Safety Management and Quality Assurance departments, to contribute to maintain/renew BMSKK Marketing Authorization license.
  • Contribute to manage manufacturers, collaborating with BMSKK Aichi Plant, contract manufacturers and other related BMSKK departments including the Global team in accordance with Pharmaceutical & Medical Device Act. and other related regulations.
  • As expert of Post-Marketing regulatory, manage the regulatory compliance for manufacturers, and contribute in supplying high quality BMSKK product stably as well.


Position Responsibilities
  • Manage HA inspection to contribute to maintain/renew BMSKK Marketing Authorization license.
  • Coordinate Global audit for GQP/GDP and lead the preparation of audit.
  • In order to ensure regulatory compliance as a MAH and improve the quality of tasks, execute the self-inspection according to GXP ordinances.
  • To minimize the risk to the business, and manage and support people in charge regarding CAPA.
  • Properly set up and facilitate the information sharing meetings with the four responsible persons on GXP (including GPSP), and create and save accurate minutes.
  • Involving the business alliance partnersand internal and external stakeholders, plan and execute mock recall of products after release, and lead people in charge to perform the necessary actions (revision of procedures, addition of R & R of personnel in charge, etc.).
  • Supervise discrepancies between the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing situations.
  • Periodically confirm discrepancies between the approved file (site information, manufacturing processes, testing items and other necessary information) and the actual manufacturing situations. If discrepancies is found, plot regulatory strategy and take appropriate actions to the authority by coordinating with associated departments.
  • Formulate and propose the regulatory strategy such as GMP /GCTP Compliance Inspection application and. Also, complete these tasks as scheduled.


Degree Requirements
  • University Bachelor of Science or Master of Science in Science
  • Pharmacist license: desirable


Experience Requirements
  • GQP/GMP/GCTP/GVP operations
  • Regulatory application for manufacturing control and quality control operations including post-marketing pharmaceutical affairs.
  • Quality control testing operation, pharmaceutical production or packaging operations at the manufacturing sites.


Key Competency Requirements

Knowledge
  • Knowledge of Pharmaceutical & Medical Device Act. and related regulations, GQP ministerial order and GMP ministerial order.
  • Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.


Skills
  • Communication / negotiation skills to build good relationships with regulators and relevant departments.
  • Strong leadership to Basic knowledge of DS/DP manufacturing, packaging operation, quality control testing and Japanese Pharmacopoeia.
  • drive cross-functional tasks.
  • Logical thinking to develop management strategies.
  • General project management skills, including problem solving.
  • Ability to propose problem solutions related to safety management and quality assurance.
  • Ability to propose measures to minimize business impact on risks related to the stable supply of products.


Language skills
  • Be able to communicate with overseas representatives through meetings and e-mail
  • Have ability to understand English materials related to work


Travel Required (nature and frequency).

Minimal travel required. Travel to BMS site in Japan, 1 -2 days each trip, 1-2/year..

ポジション概要
  • 製造販売業者における安全性及び品質に関するガバナンスを強化し,規制遵守,患者の安全性及び高品質な安定的な製品供給を確保する
  • ステークホルダー管理およびリスク管理を通じて,BMSKKの事業に貢献するにあたり,最高製薬責任者を補佐し,サポートする.
  • 規制,安全管理,品質保証の各部門と協力し,BMSKK販売承認ライセンスの維持/更新に貢献する.
  • BMSKK愛知工場,委託製造業者及びグローバルチームを含むその他関連BMSKK部門と医薬品医療機器等法に基づき連携し,製造業者の管理に協力する. その他の関連規制
  • 市販後規制の専門家として,製造業者の規制コンプライアンスを管理し,高品質なBMSKK製品の安定供給にも貢献する.


ポジションの責任
  • HA検査を管理し,BMSKK販売承認ライセンスの維持/更新に貢献する.
  • GQP/GDPのグローバル監査を調整し,監査の準備を指揮する.
  • MAHとして規制遵守を確保し,業務の質を向上させるため,GXP条例に従い自己点検を実施する.
  • 事業へのリスクを最小化し,CAPAに関する担当者を管理・サポートする.
  • GXP上の責任者4名(GPSP含む)との情報共有会議を適切に設定・推進し,正確な議事録を作成し,保存する.
  • 業務提携先や社内外のステークホルダーを巻き込み,出荷後の製品の模擬回収を計画・実行し,責任者を主導し,必要なアクション(手順の見直し,担当者のR&Rの追加等)を実施する.
  • 承認されたファイル(サイト情報,製造プロセス,試験項目,その他の必要な情報)と実際の製造状況との不一致を監督する.
  • 承認済みファイル(施設情報,製造工程,試験項目,その他必要な情報)と製造実態との乖離を定期的に確認する. 不一致が見つかった場合は,規制戦略を立案し,関連部門と調整して当局に適切な措置を取る.
  • GMP/GCTPコンプライアンス査察申請などの規制戦略を策定し,提案する. また,これらのタスクをスケジュールどおりに完了してください.


学位要件
  • 科学の学士号または科学の修士号
  • 薬剤師免許:望ましい


経験要件
  • GQP/GMP/GCTP/GVP業務
  • 製造販売後薬事を含む製造管理及び品質管理業務の薬事申請
  • 製造所における品質管理試験業務,医薬品製造又は包装業務


主なコンピテンシー要件

知識
  • 医薬品医療機器等法に関する知識 および関連規制,GQP省令およびGMP省令.
  • 外国製造業者認定の取得/更新およびGMP/GCTPコンプライアンス検査などの規制申請に関する知識


スキル
  • 規制当局および関連部門と良好な関係を築くためのコミュニケーション/交渉スキル.
  • DS/DP製造,包装業務,品質管理試験,および日本薬局方に関する基本的な知識に対する強力なリーダーシップ.
  • 部門横断的なタスクを推進する.
  • 経営戦略を策定するための論理的思考.
  • 問題解決を含む一般的なプロジェクト管理スキル
  • 安全管理と品質保証に関連する問題ソリューションを提案する能力.
  • 製品の安定供給に関連するリスクに対するビジネスへの影響を最小限に抑えるための措置を提案する能力.


言語スキル
  • 会議や電子メールを通じて海外の担当者とコミュニケーションを取ることができる
  • 仕事に関連する英語の資料を理解する能力がある


必要な出張(性質と頻度)
  • 最低限の旅行が必要です. 日本のBMS施設への出張,1回につき1~2日,1~2日/年.


If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Company

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

 

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

 

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