Manager, Japan QA Operations CART

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.

PURPOSE AND SCOPE OF POSITION:

• To provide Quality oversight of Contract Manufacturing Organizations (CMOs, which includes logistic service provider) in support of BMS’s Cell Therapy operations in Japan.
• To partner and provide support to the Responsible Person for Quality Assurance with respect to drug product disposition and distribution in Japan.

REQUIRED COMPETENCIES:

Education:Master’s degree or bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.

Experience

REQUIRED

• More than 5 years’ experience in regulated environment (cGMP/GCP/GCTP) with a minimum of 3 years’ experience in quality assurance.
• Strong organizational skills, including ability to follow assignments through to completion.
• Advanced skills in leading, influencing, and negotiating in order to manage CMOs appropriately.
• Advanced knowledge of relevant regulations and guidance; available to act as a resource for colleagues.
• Independent decision-making capability and ability to think conceptually and understand impact of decisions.
• Flexibility in responding to change or business needs
• Advanced verbal and written communication skills in Japanese and English.
• Ability to work in cross functional teams

PREFFERED

• Experience within the Cellular Therapeutics environment
• Experience with Commercial products and clinical products
• Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition
• Ability to prioritize and successfully manage complex and competing projects
• Detail-oriented with expertise in problem solving and solid decision-making abilities
• Ability to work in a fast-paced environment

DUTIES AND RESPONSIBILITIES:

• Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR-T) product manufacturing.
• Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions, master service and/or quality agreements and applicable regulatory requirements.
• Responsible for batch record review for disposition
• Responsible for review and/or approval of CMO deviation investigations, CAPA, controlled documents (Master Batch Records)
• Act as QA impact assessor and reviewer/approver of CMO related changes
• Responsible for review and/or approval of COI risk assessment and process map
• Responsible for quality risk assessment
• Support in data auditing and review of protocol/reports in support of regulatory submissions
• Develop and review/approve annual product review reports generated by CMOs
• Collaborate with Global Quality Systems and ensure CMO’s timely implementation of corrective actions resulted from BMS’s audits
• Partner with stakeholders across different operational functions to define projects in order to improve processes and represent the quality organization in implementation phase
• Drive, lead and oversee quality related improvement projects in collaboration with affected CMO functions
• Support in setting and follow up of CMO related key performance indicators (KPI) and metrics
• Provide Quality oversight of routine operations for distribution center responsible for disposition and distribution of finished cell therapy product (CAR-T) in Japan
• Partner and provide support to the Responsible Person for Quality Assurance of commercial product (Hinseki) with respect to finished drug product release for Japan
• ​Support Logistic QA tasks.

ポジションの目的と範囲：

• 日本におけるBMSの細胞療法業務を支援するため、製造受託機関（物流サービスプロバイダーを含むCMO）の品質監視を行う。
• 日本における医薬品の処分および流通に関して、品質保証責任者と連携し、サポートを提供する。 

必要なコンピテンシー：知識、スキル、能力：

教育：生化学、生物学、微生物学、化学、工学、薬局、または密接に関連する分野の修士号または学士号。 

経験

必須

• 規制環境（cGMP/GCP/GCTP）における5年以上の経験、および品質保証における3年以上の経験
• 任務を最後まで遂行する能力を含む、優れた組織スキル。
• CMOを適切に管理するための指導、影響力、交渉の高度なスキル。
• 関連する規制やガイダンスに関する高度な知識。同僚のリソースとして利用できる。
• 独立した意思決定能力と、概念的に考え、意思決定の影響を理解する能力。
• 変化やビジネスニーズへの対応における柔軟性
• 日本語と英語の高度な言語および書面によるコミュニケーションスキル。
• 部門横断的なチームで働く能力

歓迎要件

• セルラー セラピューティクス環境における経験
• 市販製品および臨床製品の経験
• プロセスマッピング、根本原因分析、問題定義を含む、プロセスエクセレンス/シックスシグマ手法およびアプローチなどの高度なプロジェクト管理スキル
• 複雑で競合するプロジェクトに優先順位を付け、うまく管理する能力
• 問題解決の専門知識と確固たる意思決定能力を備えた詳細志向
• ペースの速い環境で作業する能力

職務および責任：

•  細胞療法（CAR-T）製品の製造をサポートするため、CMOでの日常業務の品質監視を行う。
• CMO品質部門と連携し、製造業務を監督し、承認された規制当局への提出物、マスターサービスおよび/または品質契約、ならびに適用される規制要件に従って作業が実施されるようにする。
• 処理のバッチレコードレビューに責任を持つ
• CMO逸脱調査、CAPA、管理文書（マスターバッチ記録）の審査および/または承認に責任を負う
• CMO関連の変更のQA影響評価担当者およびレビュー担当者/承認者として行動する
• COIリスク評価およびプロセスマップのレビューおよび/または承認に責任を負う
• 品質リスクアセスメントの責任者
• 規制当局への提出をサポートするため、データ監査および治験実施計画書/報告書のレビューをサポートする
• CMOが作成した年次製品レビューレポートを作成、レビュー/承認する
• グローバル品質システムと協力し、CMOがBMSの監査から是正措置を適時に実施できるようにする
• 異なる業務部門のステークホルダーと協力してプロジェクトを定義し、プロセスを改善し、実施段階で品質組織を代表する
• 影響を受けるCMO部門と協力して、品質関連の改善プロジェクトを推進、主導、監督する
• CMO関連の主要業績評価指標（KPI）と指標の設定とフォローアップのサポート
• 日本における完成細胞療法製品（CAR-T）の処分および流通を担当する流通センターの日常業務の品質監視を行う
• 日本向け最終製品出荷について、市販品（Hinseki）の品質保証責任者と連携し、サポートする
• ロジスティックQAタスクをサポートする。

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
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.