【JOPS】Project Leader for NPI and Supply Chain Projects, JOPS SCM
■ 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＞
【キャリアレベル / Career Level】
【勤務地 / Work Location】
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.