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【JOPS】Project Leader for NPI and Supply Chain Projects, JOPS SCM

Location Osaka, Ōsaka, Japan Job ID R-140663 Date posted 23/06/2022


■ 職務内容 / Job Description

Role as Project Leader at launch site
The role of the Project Leader is to lead and deliver Supply Chain projects such as NPIs, TTs, New Launches, Deals and othersin Japan OPS, according to established standard processes, to the agreed timelines and costs. 
Role responsibilities also include project team management, stakeholder management and project communications. It is key for the role holder to understand the customer needs and constrains and to act and lead in an environment with uncertainties and changing assumptions/requests.
This work involves management and oversight of the process establishment to ensure both regulatory and commercial manufacturing readiness in Japan OPS. It also involves preparation, manufacturing and supply of launch stock volumes to meet the forecasted demand from the worldwide markets. 
The scope includes both manufacturing and quality control and could cover one up to packaging steps, and high level all steps in the Supply Chain, from raw material procurement to drug substance, drug product, fill, finish, final assembly and packaging. It also includes handover to BAU activities at the site once the new product matures in its lifecycle, MA transfer/divestment/Due Diligence activities in its lifecycle too.
The Project Leader is the Single point of contact from the launch site and the role holder will be expected to represent Japan OPS both internally (GST, GOLT, PT&D/CMC teams, JPT, JNDA, CBT and others) and externally when appropriate.
The role holder shows enterprise leadership when integrating in Global teams like the GST and GOLT to deliver benefit and value cross functionally, regionally and globally.

The role holder may also be the launch site representative in Global NPI process networks.

General Project/Programme accountabilities
•    Lead cross-functional NPI/Supply Chain projects within Japan OPS, involving establishment as well as launch supply to markets.
•    Establishing and leading site NPI/Supply Chain project teams in accordance with the AZ Project Management Framework (PMF) in order to deliver project objectives efficiently and effectively.
•    Facilitate the resolution and handling of a wide range of complex problems with cross-functional team.
•    Manage resources and motivate project team members to promote high performance.
•    Continuously reviews plan execution against target.  Proactively identify potential risks, issues and opportunities, develop alternatives balancing business needs and costs, and ensure key contributors and stakeholders are fully aware of changes and developments. Escalates when decision rights exceed established boundaries.
•    Establishes strong working relationships with key internal and external customers and demonstrates personal ownership and accountability for results with a focus on project execution and customer service.  
•    Support to manage budget costs & benefits associated with their project/programme on behalf of launch site/Operations.
•    Manage changes to project scope
•    Utilize lean concepts and tools within the overall management of projects.  Within NPI/Supply Chain project embed lean concepts within solutions and drive continues improvements.
•    As a responsible leader, maintain effective employee relations and compliance to cGMP, GDP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards
•    When appropriate, lead and manage deal projects(MA transfer/divestment/Due Diligence /tech transfer, other business) in Japan OPS

Accountabilities specific for Project Leader•    Act as a team member in Global teams such as GST and GOLTs. Collaboratively drive team activities forward and raise any potential GAPs/issues to relevant team
•    Act as a representative of Japan OPS in AZKK teams such as JPT, JNDA and CBTs. Collaboratively drive team activities forward and raise any potential GAPs/issues to relevant team
•    Coordinate the activities and decision-making processes of a diverse group of multi-functional Site experts.  Understands the consequences and possible alternatives to complex technical issues and effectively communicates their impact to a wide audience within the organization.
•    Understand on a high level the implications of packaging configurations, anticipated volumes, third- party services and customer constrains.
•    Linking cross sites to other NPI-leads/Supply Project Lead involved in GST/GOLT. Potential issues/conflicts to be highlighted and managed/facilitated in GOLT or GST.
•    Lead and drive establishment activities (Technology Transfer of packaging processes of NPIs) at site and ensure completed to meet regulatory timelines and launch readiness, all in accordance to global and local NPI processes. 
•    Facilitates the NPI/Supply Chain project development process by providing other global team members with an understanding of the site's manufacturing capabilities. 
•    Lead and drive Site activities and preparations to successfully deliver launch material as agreed with Marketing Companies
•    Communicates the implications of multiple project execution on the organization; ensures all internal colleagues are aligned to provide equipment, materials, and services to support the completion of the project. 
•    Support the inspection readiness team for Preapproval inspection readiness of NPIs/TTs.
•    Ensure that there will be smooth handover into business as usual and that there are minimum negative effects on core business activities as a consequence of project execution.
•    Share best practices with other Operations NPI/Supply Chain project Leads. 

The complexity of leading NPI/Supply Chain projects at sites will depend on product characteristics, Supply Chain set up, market scope, business model and launch expectations. Project with higher complexity requires additional or stronger capabilities together with more experience and higher business acumen. Senior Project lead is assigned high complex project.

■ 応募資格(経験、資格等)/ Qualification (Experience & Skill etc)

【経験 / Experience】

<必須 / Mandatory>

•As Supply Project-lead, it is essential to have following Education and Experience: Bachelor’s degree required in engineering, pharmacy, chemistry or related science, or business related field.
•5 years of experience in and demonstrated knowledge in various aspects of the pharmaceutical industry usually including experience in at least two of the following areas: 
Establishment phase: manufacturing management, supply chain management, product development, regulatory/quality assurance, process technology and engineering
Launch phase: manufacturing management, supply chain management, logistics and distribution, finance or commercial.

【資格 / License】

<歓迎 / Nice to have>

 • Project Management certification

【能力 / Skill-set】

<必須 / Mandatory>

As Supply Project-lead it is essential to demonstrate Project management skills:
• Demonstrated project management skills
• Proven experience in successfully delivering business-critical projects/programs involving cross-functional participants, stakeholders and organizations
• Demonstrated ability to create detailed project plans, meet schedules and timelines, and handle multiple priorities.  Ability to plan and execute multiple project tasks and multiple projects concurrently

The Leadership skills are essential for the Supply Project-lead:
• Strong leadership, interpersonal, influencing and communication skills (level is specified in Section “Values and Capabilities”)
• Demonstrated ability to foster high performance teamwork and establish strong working relationships with key stakeholders.  PD/Applicable when working with partners/CMOs
• Demonstrated ability to effectively collaborate and communicate with team members and all levels of management and/or represent the Department in key leadership forums. PD/Applicable when working with partners/CMOs

 As Supply Project-lead it is essential to also demonstrate skills or experience in:
• Ability to drive results as well as take balanced risks and drive decisions.
• Effectively cope with change and is comfortable changing direction and acting without complete information
• Sound judgement, good business acumen and strong analytical skills
• Dealing with a wide range of problems that require well developed conceptual thinking and judgement to find solutions.
• Critical thinking, influence, negotiation, problem solving, strategic thinking, and leadership in a matrix environment. 

As Supply Project-lead it is essential to have knowledge and understanding of:
•AZ business processes and procedures
• Current Good Manufacturing Practices (cGMPs)
• Good Distribution Practices (GDPs)
• Lean principles and practices
• General and high level process of JNDA

In additional, when leading more complex projects or a program it is also essential to have:
• Program management skills, including the ability to foster excellent team dynamics and resolve conflicts
• Ability to connect and collaborate with cross-functional departments across all levels of the organization (e.g., Operations, Quality, Supply Chain, Finance, PT&D, Marketing and Global Operations Leadership Team) to enable development and execution of realistic plans.
• A comprehensive understanding of Operations as well as a strong understanding of other functions and how they contribute to the objectives of the business.

<歓迎 / Nice to have>

•    Knowledge and understanding of all aspects of product life cycle management
•    Experience with commercialization and launch of new products
•    Knowledge and experience of logistics and planning
•    Knowledge of Pharmaceutical Low/Pharmacopeia/Drug approval and licensing procedures in Japan
•    Knowledge of and experience with lean concepts and tools
•    Technical/expert Knowledge and experience of CMC/manufacturing/product development/quality/regulatory
•    Demonstrated understanding of external customer base and supply chain
•    Proficient in MS suite of software tools (PowerPoint, Excel, Word, Project)

【語学 / Language】

<必須 / Mandatory>

日本語 Japanese:Fluent

英語 English:Fluent

【キャリアレベル / Career Level】


【勤務地 / Work Location】



【JOPS】オペレーション本部サプライチェーンマネジメント部 NPI・サプライチェーンプロジェクトのプロジェクトリーダー


オペレーション本部において、NPI(New Product Introduction, 新製品導入)、TT(Tech Transfer, 製造技術移管)、他社からの導入や導出・他社への供給などのオペレーション本部における部門横断的なサプライチェーンプロジェクトを、確立された標準プロセスに従って、合意されたスケジュールとコストで主導し、遂行する。 
プロジェクト目標に対する継続的なレビューを行い、 潜在的なリスク、問題、機会を特定し、問題解決にリーンの概念を組み込み継続的な改善を推進の上、ビジネスニーズとコストのバランスを考慮した代替案を作成する。裁量権の範囲を超えた場合は、エスカレーションを行う。
職務範囲は製造と品質管理・保証の両方を含み、包装工程や、原材料の調達から原薬、製剤、充填、仕上げ、最終組立、包装まで、サプライチェーンにおける全工程が含まれる可能性がある。それらの専門家で構成される多様なメンバーのグループにおける活動や意思決定プロセスをとりまとめ、 複雑な技術的問題の影響と可能な代替案を理解し、その影響を組織内の幅広い対象者に効果的に伝える。また責任あるリーダーとして、職場での効果的な人間関係を維持し、cGMP、GDP、その他の規制、SOX要件、SHEの義務、AZスタンダードへの準拠を維持する。 

なお、 サイトにおけるNPI/サプライチェーンプロジェクトの複雑さは、製品特性、サプライチェーンの構成、市場の範囲、ビジネスモデル、上市の見込みによって異なるため、より複雑なプロジェクトではより多くの経験やビジネスセンスとともに、さらなる能力、またはより高度な能力が必要とされる。シニアプロジェクトリーダーは、より複雑なプロジェクトを担当する。


•製薬業界の様々な側面における 5 年間の経験と実務知識(通常、以下の分野のうち少なくとも 2 つを含む)。 

 • プロジェクト管理の資格

• 部門横断の参加者、ステークホルダー、組織を含むビジネスクリティカルなプロジェクト/プログラムを成功させた実績
• 詳細なプロジェクト計画を作成し、スケジュールとタイムラインを守り、複数の優先順位に対応する能力を発揮した実績。 複数のプロジェクトタスクと複数のプロジェクトを同時に計画・実行する能力。
• 強力なリーダーシップ、対人能力、影響力、コミュニケーション能力
• 高パフォーマンスのチームワークを育み、主要なステークホルダーと強固な業務関係を構築する能力
• チームメンバーやあらゆるレベルの管理職と効果的に協働し、コミュニケーションを図る能力、および/または主要なリーダーシップフォーラムで部門を代表する能力
• バランスの取れたリスクを取り、決定を下すだけでなく、結果を導く能力。
• 変化に対応し、情報が不十分でも方向転換し、行動することができる能力
• 適切な判断力、優れたビジネス洞察力、強力な分析スキル
• クリティカルシンキング、影響力、交渉力、問題解決、戦略的思考、マトリックス環境でのリーダーシップ。 
• 現行医薬品適正製造基準(cGMP)
• 適正流通基準 (GDP)
• リーンの原則と実践
• JNDAの一般的なプロセスおよび全体像

• 優れたチームダイナミクスを醸成し、対立を解決する能力を含む、プログラムマネジメントのスキル
• 現実的な計画の策定と実行を可能にするために、組織のあらゆるレベルの部門(オペレーション、品質、サプライチェーン、財務、製剤開発部門、マーケティング、グローバルオペレーションリーダーシップチームなど)と部門横断で連携・協働する能力。
• オペレーション部門を総合的に理解し、他の部門についても深く理解し、それらがどのように会社の目標に貢献しているかを理解していること。

•    製品ライフサイクルマネジメントに関する知識・理解
•    新製品の商業化・上市の経験
•    ロジスティクスやプランニングに関する知識・経験
•    日本における薬事法、薬局方、薬事承認、許認可手続きに関する知識
•    リーンの概念とツールに関する知識と経験
•   CMC/製造/製品開発/品質/規制に関する技術的/専門的な知識と経験
•    社外顧客ベースとサプライチェーンに関する理解
•    MS ソフトウェアツール(PowerPoint、Excel、Word、Project)に習熟していること

10000621 D SUGE Operations

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