EM Associate Manager

Category:  Manufacturing
Location: 

Tianjin, Tianjin, CN

   

 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年和2020年连续两年荣获Kincentric“最佳雇主称号。

 

At Novo Nordisk we recognise 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 the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

Qualifications (minimum requirements) 任职资格

 

Education 教育背景

  • Bachelor degree or above in Pharmacy, Engineering, bioengineering, or related field

 

  • Fluent in written and spoken English

    Professional experience 专业经验

  • Minimum 5 years quality- or production-related experience in
  • cGMP regulated pharmaceutical industry

  • Previous experience in aseptic production with demonstrated expertise in monitoring, cleaning, and
  • sampling is highly desirable

  • Previous supervisory, management and/or project management experience highly desirable
  • Previous experience using LEAN/cLEAN tools
  • Work experience in cross function team environment

Job content 工作内容描述

 

Key areas of responsibility 主要工作职责:

  • Build up and maintain a strong EM professional team to ensure the team has the competence to handle all the GMP tasks, including audits, compliance and deviations.
  • Ensure deviations, excursions, and trends are investigated and resolved adequately
  • Improve aseptic assurance continuously to avoid production stop due to DV and avoid worse case recalls from market
  • Support production team in proactive way
  • Plan EM activities to assure compliance and delivery

 

Main job tasks 主要工作任务:

Lead the EM professional team to ensure GMP compliance, product quality and release to the market.

  • Ensure Quality document (SOP, DV, CR, etc) is handled correctly and timely
  • Ensure Compliance report (QMR, EM Trend, CCS, etc) is handled correctly and timely
  • Ensure an effective program for aseptic behavior training is in place and carried out
  • Ensure over limit samples, negative trends, and incidents are investigated adequately and corrective and preventative actions are implemented as needed
  • Drive DV set up & understanding
  • Drive complex DV and systematic problem solving to ensure sufficient CAPA is taken
  • Handling authority audits and other regulatory affairs issues related to the Environmental Monitoring
  • Ensuring safe working environment and compliance with internal and external EHS requirements
  • Coach employees in DV, CR, general GMP understanding and trouble shooting
  • Develop plans to improve performance and efficiency using cLEAN concepts

Responsible of People management

  • Develop efficient processes for running day-to-day operations in EM professional team
  • Ensure EM professionals are appropriately trained to perform job tasks
  • Continuous improvement through use of cLEAN leadership principles and tools
  • Interviewing and hiring personnel
  • Goal-setting and performance evaluation

Plan and coordinate support from other departments inside and outside of PS Site

  • Tianjin
  • Ensuring safe working environment and compliance with internal and external EHS requirements
  • Substitute and sign documents on behalf of EM manager in his/her absence

Responsible of Change management

  • Establish a culture based on continuous improvements
  • Use cLEAN Leadership model as a platform for managing performance, people and improvements.

Prepare and deliver change communication

Other individual assignments 其他工作任务:

 Other tasks as assigned

Supplementary job description 辅助工作描述

 

Degree of independent decisions 独立决定的程度

  • Must be able to handle complex and important decisions with several function departments involved

Very high degree of independent decision making in own area

Level of independence, innovation and initiative 独立性,创新和主动的级别

  • There will be a very high level of independence.

Successful delivery of the main tasks will rely on very high levels of initiative, innovation, leadership, influence, process improvement knowledge and management skills

Main stakeholders / reputation and results 主要联络对象

  • AP EM manager and other managers in AP management team
  • AP production supervisors and employees
  • STJ internal functions in other areas (PS, QC, etc)
  • EM in other IFP sites

DFP core process group

Degree of influence on departmental/function/NN results 对部门/职能/NN结果的影响度

Very high degree. Decisions from this department could impact the overall site strategy both in terms of Quality (batches rejected, DVs) as well as Business Indicators (Productivity, Lead time).

Communication / Interaction with other internally or externally 内部或外部的沟通

The position plays an active role in ensuring delivering the business result of AP. From communication/interaction perspective this includes:

  • Communicate decisions and initiatives
  • Communicate with stakeholders at director, managers and supervisor level
  • Communicate and collaborate with stakeholders from many parts of the global Novo Nordisk organization
  • Challenge "the way as it is", drive and persue continuous improvement
  • Has good change management skills and can prepare and deliver change communication
  • Has a global mindset and be able to work cross-culture

Has very diverse professional and/or cultural background

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.