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QMS specialist for international manufacturing operations

  • Legal, Compliance and Audit
  • Field-based

Would you like to use your pharmaceutical expertise to impact, support and challenge the quality mindset in an international and diverse production landscape? Are you ready for an exciting opportunity to work with colleagues across Iran, Algeria, Russia, India, Bangladesh and other exciting countries along with a broad range of stakeholders?

About the department
Local Manufacturing (LM) is part of Novo Nordisk’s Product Supply organisation and consists of 700 employees of which approximately 50 are in Denmark. The primary role of LM is the establishment and operation of manufacturing sites in countries where local presence is required in order to obtain market access.

 

LM consists of both Novo Nordisk owned sites as well as partnering with contract manufacturing organisations (CMO’s) and joint ventures. The job is located in Bagsværd, Denmark, however the job will require around 40 days of travel activity annually.

The position
Your overall focus in this position is to coordinate and ensure quality and compliance in a GMP regulated area.

You are an ambassador of the LM quality strategy towards internal and external stakeholders on the sites, QA and the manufacturing development organisations. This includes sharing knowledge and best practices across the organisation on various QMS/GMP topics.

 

In particular, you will further develop, implement and ensure an adapted Quality Management System (QMS) structure for the entire LM global organisation in accordance to EU regulations. Together with your stakeholders, you will be instrumental in identifying areas for improvements which can lift our quality level and you will then be a part of prioritising for implementation.

 

This position gives you an exceptional opportunity defining and developing new quality standards while considering smaller local manufacturing facilities and their ability to manoeuvre in the regulatory landscape. Your ability to network with the local organisation in the LM countries and across Novo Nordisk understanding local culture and work environment will be key to your success.

 

You will be anchored in the Danish part of the organisation. Meaning, also having hands on daily operational tasks e.g. deviations and change requests and giving your support and expert advice when relevant.

 

Qualifications
Your educational background could be a MSc or equivalent within pharmacy, chemistry, engineering or similar. You have at least 10 years of relevant experience from the pharmaceutical industry. You have a thorough knowledge of QMS and GMP standards and know how to interpret and implement them for market production of drug products from positions in Quality Assurance, manufacturing and/or Regulatory Affairs.

 

As a person, you have an intuitive high quality mindset and are passionate about quality, compliance and improvements. You work independently in a structured and systematic way and you can communicate in a direct and clear manner to all organisational levels. You have a strong drive, are energetic and eager to move the organisation to the next level within quality. Knowing when to be pragmatic and when to stand firm on requirements is expected. Additionally, you enjoy communicating and cooperating with a diverse range of stakeholders and know how to operate in a cross-cultural organisation with a high pace.

 

Excellent command of written and spoken English is a prerequisite.


Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for patients around the world. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Carsten Poulsen at +45 3075 3735.

Deadline

19 January 2020. Please note that interviews will be held on a continuous basis.

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.


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330157033Phoenix-5125783912020-01-14T00:00:00QMS specialist for international manufacturing operations
  • Legal, Compliance and Audit
  • Field-based

Would you like to use your pharmaceutical expertise to impact, support and challenge the quality mindset in an international and diverse production landscape? Are you ready for an exciting opportunity to work with colleagues across Iran, Algeria, Russia, India, Bangladesh and other exciting countries along with a broad range of stakeholders?

About the department
Local Manufacturing (LM) is part of Novo Nordisk’s Product Supply organisation and consists of 700 employees of which approximately 50 are in Denmark. The primary role of LM is the establishment and operation of manufacturing sites in countries where local presence is required in order to obtain market access.

 

LM consists of both Novo Nordisk owned sites as well as partnering with contract manufacturing organisations (CMO’s) and joint ventures. The job is located in Bagsværd, Denmark, however the job will require around 40 days of travel activity annually.

The position
Your overall focus in this position is to coordinate and ensure quality and compliance in a GMP regulated area.

You are an ambassador of the LM quality strategy towards internal and external stakeholders on the sites, QA and the manufacturing development organisations. This includes sharing knowledge and best practices across the organisation on various QMS/GMP topics.

 

In particular, you will further develop, implement and ensure an adapted Quality Management System (QMS) structure for the entire LM global organisation in accordance to EU regulations. Together with your stakeholders, you will be instrumental in identifying areas for improvements which can lift our quality level and you will then be a part of prioritising for implementation.

 

This position gives you an exceptional opportunity defining and developing new quality standards while considering smaller local manufacturing facilities and their ability to manoeuvre in the regulatory landscape. Your ability to network with the local organisation in the LM countries and across Novo Nordisk understanding local culture and work environment will be key to your success.

 

You will be anchored in the Danish part of the organisation. Meaning, also having hands on daily operational tasks e.g. deviations and change requests and giving your support and expert advice when relevant.

 

Qualifications
Your educational background could be a MSc or equivalent within pharmacy, chemistry, engineering or similar. You have at least 10 years of relevant experience from the pharmaceutical industry. You have a thorough knowledge of QMS and GMP standards and know how to interpret and implement them for market production of drug products from positions in Quality Assurance, manufacturing and/or Regulatory Affairs.

 

As a person, you have an intuitive high quality mindset and are passionate about quality, compliance and improvements. You work independently in a structured and systematic way and you can communicate in a direct and clear manner to all organisational levels. You have a strong drive, are energetic and eager to move the organisation to the next level within quality. Knowing when to be pragmatic and when to stand firm on requirements is expected. Additionally, you enjoy communicating and cooperating with a diverse range of stakeholders and know how to operate in a cross-cultural organisation with a high pace.

 

Excellent command of written and spoken English is a prerequisite.


Working at Novo Nordisk
At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for patients around the world. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Carsten Poulsen at +45 3075 3735.

Deadline

19 January 2020. Please note that interviews will be held on a continuous basis.

 

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.

2020-02-17T18:51:07.483 Legal, Compliance and Audit Field-based Would you like to use your pharmaceutical expertise to impact, support and challenge the quality mindset in an international and diverse production landscape? Are you ready for an exciting opportunity to work with colleagues across Iran, Algeria, Russia, India, Bangladesh and other exciting countries along with a broad range of stakeholders? About the department Local Manufacturing (LM) is part of Novo Nordisk s Product Supply organisation and consists of 700 employees of which approximately 50 are in Denmark. The primary role of LM is the establishment and operation of manufacturing sites in countries where local presence is required in order to obtain market access. LM consists of both Novo Nordisk owned sites as well as partnering with contract manufacturing organisations (CMO s) and joint ventures. The job is located in Bagsværd, Denmark, however the job will require around 40 days of travel activity annually. The position Your overall focus in this position is to coordinate and ensure quality and compliance in a GMP regulated area. You are an ambassador of the LM quality strategy towards internal and external stakeholders on the sites, QA and the manufacturing development organisations. This includes sharing knowledge and best practices across the organisation on various QMS GMP topics. In particular, you will further develop, implement and ensure an adapted Quality Management System (QMS) structure for the entire LM global organisation in accordance to EU regulations. Together with your stakeholders, you will be instrumental in identifying areas for improvements which can lift our quality level and you will then be a part of prioritising for implementation. This position gives you an exceptional opportunity defining and developing new quality standards while considering smaller local manufacturing facilities and their ability to manoeuvre in the regulatory landscape. Your ability to network with the local organisation in the LM countries and across Novo Nordisk understanding local culture and work environment will be key to your success. You will be anchored in the Danish part of the organisation. Meaning, also having hands on daily operational tasks e.g. deviations and change requests and giving your support and expert advice when relevant. Qualifications Your educational background could be a MSc or equivalent within pharmacy, chemistry, engineering or similar. You have at least 10 years of relevant experience from the pharmaceutical industry. You have a thorough knowledge of QMS and GMP standards and know how to interpret and implement them for market production of drug products from positions in Quality Assurance, manufacturing and or Regulatory Affairs. As a person, you have an intuitive high quality mindset and are passionate about quality, compliance and improvements. You work independently in a structured and systematic way and you can communicate in a direct and clear manner to all organisational levels. You have a strong drive, are energetic and eager to move the organisation to the next level within quality. Knowing when to be pragmatic and when to stand firm on requirements is expected. Additionally, you enjoy communicating and cooperating with a diverse range of stakeholders and know how to operate in a cross-cultural organisation with a high pace. Excellent command of written and spoken English is a prerequisite. Working at Novo Nordisk At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for patients around the world. In exchange, we offer you an opportunity to work with extraordinary talent and to benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Carsten Poulsen at 45 3075 3735. Deadline 19 January 2020. Please note that interviews will be held on a continuous basis. Millions rely on us To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.11Jobnet51257839100000000000IDK_OFIR_02DKDanmark228DKK2020-03-10T00:00:000000https://www.novonordisk.com/careers/working-at-novo-nordisk/job-ad-display.26720.en_GB.html0EuropaDanmarkSjælland & øerStorkøbenhavnGladsaxe3691704NOVO NORDISK A/S11Novo Alle 12880BagsværdDKDanmark0
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8Fuldtid46Permanent10000885101JobNet5099722509972210014-01-2020000https://dispatcher.ofir.dk/statistic/register?context=FeedEntrySearchedCount&feedId=dc2beb84&entryId=51257839https://dispatcher.ofir.dk/statistic/register?context=FeedEntryDisplayCount&feedId=dc2beb84&entryId=51257839https://dispatcher.ofir.dk/statistic/register?context=JobApplicationInitiatedCount&feedId=dc2beb84&entryId=51257839&page=ShowJob&component=SendApplicationButtonhttps://dispatcher.ofir.dk/statistic/register?context=JobApplicationAppliedCount&feedId=dc2beb84&entryId=51257839&page=EmailApplyForm&component=SendApplicationButtonhttps://static.matchwork.com/company/logo/DK/ORS/SoMe/Produktion_haandvaerk_og_transport/Industri/4.jpgQMS specialist for international manufacturing operations12008001Dansk3Læse/ tale28Industri363930891Carstennoreply@ofir.comDKDanmarkDKDanmarkda-DK