This listing was posted on Novo Nordisk.
Wash & Sterilization WPO
Location:
Tianjin
Description:
诺和诺德（中国）制药有限公司天津生产厂是诺和诺德全球唯一的胰岛素耐用注射器械供应商，以及重要的胰岛素制剂与灌装生产基地，在2019年，2020年及2022年荣获Kincentric“最佳雇主”称号。 Qualifications (minimum requirements) 任职资格 Education 教育背景 • PhD, Master or Bachelor of Science, Engineering, or Pharmacy • Preferably People or Project Management training/certification • (preferably) Solid GMP training Professional experience 专业经验 • At least 5 years’ experience as people manager • Preferably experience within project management within global GxP investment projects • Preferably experience with building and ramping-up operational organization • Experience from operating in a GMP-regulated environment • Preferably good network within PS and related areas within NN • Good English skills and experienced presenter Job content 工作内容描述 Key areas of responsibility 主要工作职责 : The WPO in STJ Fill/Finish Expansion project is a key role integrated in the project management and execution team managing a strategic PS expansion project. The WPO is overall responsible for the process and automation installation, verification and operational readiness of the aseptic production (AP) part of the facility and thereby also for ensuring a close collaboration with the AP Expansions program in order to implement the project specific technical execution objectives, equipment etc. The WPO is the key driver in ensuring that the process and automation organisation is recruited and ramped up and sufficiently trained for operational readiness and that the organisation during the project phases take full ownership of the AP facility, equipment, standards and procedures. Accordingly the WPO must possess significant pharmaceutical engineering experience, be able to understand the impact of strategies and be able to pro-actively and efficiently manage a complex operation and organisation. The WPO is responsible for a budget in excess and includes the following key responsibilities: • Responsible for all Work Package activities • Project management and execution including integration and cooperation with the program mirror organisation • Leadership and cLEAN® • Quality and compliance Main job tasks 主要工作任务 : 1. Responsible for all Work Package activities • Collaboration with the AP Expansions program team (CORE) on development of requirements and selection of vendors of all equipment. • Manage installation of equipment and processes within Work Package according to the standards specified by the CORE • Collaboration with CORE on development of validation strategy and performance of validation of equipment and processes including documentation • Ensure local documentation for the whole package in accordance with GMP and NN SOP’s • Build organization towards operational readiness and manage recruitment of TL’s, operators, technicians and professionals • Manage development of SOP’s and training plans - and execution of training 2. Project management and project execution • Provide clear goals and purpose for the work package and the project team members so that the project secures effective use of time and resources and builds employee motivation • Create and develop the project plan with effective and transparent systems, structures, and processes • Monitor and control project work with stringent follow-up on quality, schedule, and budget so that the project delivers the desired end-product • Ensure that the right number of resources and competences is allocated to the project, negotiate project resources with LoB management and manage these resources during project execution • Report project performance to the relevant stakeholders • Perform integrated change control on the project • Archive all key project and test documents in compliance with good documentation practices. 3. Leadership and cLEAN® • Responsible for the members of the team, ensuring that responsibility and roles, tasks and interfaces are clearly defined and understood by the whole team • Daily leadership: Feedback and coaching of employees at the shopfloor • Ensure that the Performance Board, Systematic Problem Solving (SPS) and process confirmation are carried out in a structured way • Ensure development of people • Hold timely and well-prepared talks with employees • Ensure that engagement-/working climate polls are carried out, evaluated, and handled continuously. 4. Quality and compliance • Ensure that internal and external quality and legal demands are in compliance with cGMP • The department fulfil any legal demands and are working according to current GMP-/ISO/ FDA/EMEA/QSR regulations and have the right Quality Mindset • The department is always ready for audits and inspections and that these are carried out without any actions or warning letters • The team will follow current SOP’s for all processes • All employees have documented correct training in ISO-Train in accordance with their tasks • All job functions possess the right competences by following the training agreements and making structured use of competence houses, competence matrices and Job Trainings Plans (JTP) • Ensuring there are written SOP’s describing operation and maintenance within the actual area/equipment Other individual assignments 其他工作任务 : Collaboration with CORE, equipment suppliers and engineering partners requires a good knowledge of NNWay and business ethics Supplementary job description 辅助工作描述 Degree of independent decisions 独立决定的程度 The job requires a strong flair for leadership, high degree of independence and a high degree of interaction across the entire project. It requires a high degree of authority and decision making to ensure progress and a sound knowledge of when issues and deviations need to be pro-actively elevated within project management. Level of independence, innovation and initiative 独立性，创新和主动的级别 The aim of the project is to build a completely new manufacturing facility including the implementation of isolator technology, with which Novo Nordisk has limited experience. AP Expansions aim to innovate our processes on a broader perspective and to the absolute extent possible and therefore the job will require good innovations skills and sound judgement of what will work and what will not and ability to drive this innovation across organisation. Skills of handling complexities is required and the ability to constantly seeing opportunities instead of limitations will Main stakeholders / reputation and results 主要联络对象 Internal: • Project head and project management team • AP expansions core project engineering mgmt. PVP, Director and Manager level • AP Expansions management level • AP Expansions tech & Innovation PVP, management level • IFP Sites • Other PS production units • ManDev External: • Manufactures of key equipment • Engineering partners • Site contractors and suppliers Degree of influence on departmental/function/NN results 对部门 / 职能 /NN 结果的影响度 It requires a high degree of authority and decision making to ensure progress and a sound knowledge of when issues and deviations need to be pro-actively elevated within project management. Communication / Interaction with other internally or externally 内部或外部的沟通 • Communicate frequently and structured on both a management level as well as on a technical/engineering level • Efficiently setting and managing expectations • Communicate the direction and project plan to the project team and stakeholders in a compelling manner • Manages senior stakeholders and external expectations using relevant change management techniques. Bridges any gaps between various expectations and project deliverables. Turns both presentations and discussions with senior stakeholders into constructive dialogues. Facilitate meetings and discussions with stakeholders, and manage output • Communicate learnings from external networks to relevant Novo Nordisk stakeholders to leverage network relationship We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Company:
Novo Nordisk
Posted:
July 2 on Novo Nordisk
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