【 Brief Job Description 】

New Product Introduction (NPI) Lead for a product at a Launch Site.

【 Job Responsibilities 】

Role as NPI Lead at launch site

The role of the NPI Lead is to lead and deliver NPI projects in 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.

The NPI lead 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, PDT/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 projects within Japan OPS, involving establishment as well as launch supply to markets.
• Establishing and leading site NPI 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 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(divestment, tech transfer, other business) in Japan OPS same as NPI projects

Accountabilities specific for NPI-lead

• 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 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 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.
• 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 Leads.

【 Typical Accountabilities 】

Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role.  Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time.   Report potential issues of non-compliance.

Ensure and monitor compliance by team members and third parties by (a) positively reinforcing the Code of Conduct and all relevant AstraZeneca Policies and Standards, (b) ensuring completion of all required training, (c) fostering a culture of openness in which employees are comfortable raising questions or concerns,  and (d) immediately addressing and reporting, as appropriate, instances of non-compliance.

Manager Accountabilities at AstraZeneca include Ethical Conduct and Compliance, Team Management, Performance Management, Individual Development Planning, Talent Management, Recruitment, People information, SHE accountabilities, and Fiscal and Financial awareness. 

As a Leader with accountability for GXP areas - expected to understand the legal and regulatory requirements of their roles in providing appropriate resources (which could be human, financial, material, facilities, and equipment) to maintain the Quality system and continually improve its effectiveness.

【 Education, Qualifications, Skills and Experience 】

＜Essential＞

• As NPI-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.

As NPI-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 NPI-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 NPI-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 NPI-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

＜Desirable＞

• 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)
• Project Management certification

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.