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Bristol Myers Squibb Supervisor, Quality System in Nukata, Japan

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 .

概要

愛知工場のGMP上位文書がGMP要求事項及びBMS品質要求事項に準拠し、機能することを保証する責任を持つ。

  • 愛知工場GMP上位文書の各担当部門での運用状況を査察/点検し、愛知工場GMP上位文書がGMPの要求事項を満たし機能していることを保証する。

  • 愛知工場の文書管理及び教育管理のSubject Matter Expert (SME)として、BMS Globalとのコミュニケーションを持ち、システムを適切に維持する。

役割と責任範囲

  • 会社及び部門全体の方針を理解し、品質方針・品質目標・品質計画を策定する。

  • 品質方針・品質目標・品質計画をもとに品質マネジメントシステムの各プロセスを維持・管理する。

  • 各プロセスの責任者と効果的なコミュニケ―ションを取り、各プロセス責任者を指揮し、品質方針・品質目標・品質計画を実行する。

  • 以下のプロセスを通じ愛知工場サイトの法規制遵守を保証する。

  • 文書管理及び教育訓練に関して、愛知工場の責任者／システム管理者としてシステム運用の規制要求への準拠を保証する。また、システムの運用管理状況を計測するMetricsを設定して管理を行う。

  • 文書管理及び教育訓練に関して、海外チームと連携を行い、適切な維持管理を行う。

  • 愛知工場の文書全体を適切に管理するためのシステムを構築する。

  • 教育訓練プログラムの運用及び維持管理を適切に行い、従業員がGMPの作業を行う適正な能力を有することを保証する。

  • 愛知工場のBMS品質要求事項（QUALITY MANAGEMENT SYSTEM FRAMEWORK）のSite Coordinatorとして、サイトコンプライアンス評価の管理を行い、システム毎のSMEと連携し、愛知工場GMP上位文書が最新のBMS品質要求事項に適合していることを保証する。

  • 製品品質の照査（Annual Product Quality Review, APQR）のSite Coordinatorとして、規制当局及びBMS要求事項との準拠を保証する。また、関連部署と連携してAPQR作成をコーディネートするとともに、スケジュール管理を行う。

  • 製品標準書のSMEとして、規制当局及びBMS要求事項との準拠を保証する。また、製品標準書の作成及び改訂等の総合的な維持管理を行う。

  • 品質試験に関する文書レビューを行い、承認書との適合性を保証する。

その他付随業務（課共通）

  • 海外サイトとのグローバルプロジェクトに参画する。

  • 作業が効率的か常に考え、改善活動を実践する。

  • 法規制および BMS の基準等を遵守するように部署の EHS・安全衛生に責任を持つ。

必要な知識/スキル

  • 国内外のGMP要求事項及び日本の薬事対応の専門知識

  • 医薬品の品質システム業務を遂行する上での標準的な知識/スキル

  • チームメンバーに対し、スキルアップを意識した教育・指導能力

  • 品質システムの課題を見出し、実行可能な改善計画を提案できる経験能力

  • 他部門を巻き込んだプロジェクトに参加して成果を得ることができる

  • 客観的事実と外部情報、適切なリスク評価に基づき、問題を分析し、解決することが出来る。

  • 品質システムなどの課題に対し課題解決のための提案や交渉が出来る。

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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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/ (https://careers.bms.com/eeo-accessibility) 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: Bristol-Myers Squibb

Req Number: R1580515

Updated: 2024-05-02 03:21:18.939 UTC

Location: Nukata-gun-JPN

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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