■ 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.