Senior Quality Assurance Specialist

3 weeks ago


Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk Full time
Job Title: Senior QA Professional

Are you looking for a challenging role in quality assurance where you can make a significant impact in Novo Nordisk's global network of Contract Manufacturer Organizations (CMOs)?

About the Role

In this position, you will be responsible for ensuring the quality of product transfers from Novo Nordisk to Contract Manufacturing Organizations (CMOs). You will work closely with internal and external business partners to ensure compliance with relevant GMP requirements.

Key Responsibilities
  • Ensure the quality responsibility for technical transfers to CMOs and lead the implementation of quality agreements.
  • Negotiate and implement quality agreements, approve process validation strategies, and related documents.
  • Manage quality issues during technical transfers, including process validation documentations, deviations, out of specifications, change controls, and action plans.
  • Participate in qualification audits performed at CMOs and ensure sufficient follow-up on CAPAs.
Requirements
  • An academic degree in a relevant field, such as pharmacy or engineering.
  • A few years of experience in the pharmaceutical industry, either in production or QA.
  • Knowledge of quality, validation, and GMP requirements.
  • Fluency in English.
About the Department

The GCM QA Drug Substance area is responsible for quality assurance and quality support to outsourced production activities worldwide. We are a dynamic team of 35 competent people divided into 4 teams and departments, with a focus on either operations or projects.

Working at Novo Nordisk

We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work.



  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    Quality Assurance Role in Global Pharmaceutical NetworkIn this position, you will be responsible for ensuring quality processes in Novo Nordisk's global network of Contract Manufacturer Organizations (CMOs). You will participate in various projects within Active Pharmaceutical Ingredients (API) and starting material, working with both internal and external...


  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Professional to join our team at Novo Nordisk A/S. As a key member of our GCM QA Drug Substance area, you will be responsible for ensuring the quality of our outsourced production activities worldwide.Key ResponsibilitiesLead the quality responsibility for technical transfers to Contract...


  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Senior QA Professional to join our team at Novo Nordisk. As a key member of our GCM QA Drug Substance area, you will be responsible for ensuring the quality of our outsourced production activities worldwide.Key ResponsibilitiesLead the quality responsibility for technical transfers to Contract Manufacturing...


  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk AS Full time

    The position involves working as a project QA in product transfers from Novo Nordisk to Contract Manufacturing Organizations (CMOs). In this role, you will participate in various projects within Active Pharmaceutical Ingredients (API) and starting material, working with both internal and external business partners and handling tasks with high complexity and...


  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk Full time

    Quality Assurance Project Manager Job DescriptionWe are looking for a skilled Quality Assurance Project Manager to join our team at Novo Nordisk. As a Quality Assurance Project Manager, you will be responsible for ensuring quality oversight for development products, serving as the central QA in strategic project teams.Key ResponsibilitiesEnsure quality...


  • Taastrup, Høje-Taastrup Kommune, Denmark Waters Corporation Full time

    Overview At Waters Corporation, we're looking for a highly skilled Senior Instrumentation Specialist to join our team. As a key member of our Field Service Engineering team, you'll have the opportunity to work with cutting-edge technology and make a real impact in the lives of our customers. With approximately 8,000 employees worldwide, we're a leading...


  • Taastrup, Høje-Taastrup Kommune, Denmark The HubDanske Bank Full time

    About the RoleWe are seeking a highly skilled Senior Fullstack Engineer to join our team at Neurons. As a key member of our engineering team, you will play a critical role in developing and maintaining our advanced web platform.Key ResponsibilitiesTake ownership of the web platform's frontend codebase and libraries, defining and implementing new features...


  • Taastrup, Høje-Taastrup Kommune, Denmark NEURONS INC. ApS Full time

    About the RoleWe are seeking a highly skilled Senior Fullstack Engineer to join our team at Neurons Inc. ApS. As a key member of our engineering team, you will play a critical role in developing and maintaining our advanced web platform.Key ResponsibilitiesTake ownership of the web platform's frontend codebase and libraries, defining and implementing new...


  • Taastrup, Høje-Taastrup Kommune, Denmark The HubDanske Bank Full time

    About the RoleWe are seeking a highly skilled Senior Fullstack Engineer to join our team at Neurons. As a key member of our engineering team, you will play a critical role in developing and maintaining our advanced web platform.Key ResponsibilitiesTake ownership of the web platform's frontend codebase and libraries, defining and implementing new features...


  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk Full time

    About the RoleYou will be responsible for ensuring quality oversight for development projects approaching first human dose and throughout the development towards launch. This includes planning, coordinating, and tracking QA project activities in collaboration with relevant operational QA departments.As a senior QA Project Manager, you will act as QA...


  • Taastrup, Høje-Taastrup Kommune, Denmark The HubDanske Bank Full time

    About the RoleWe are seeking a highly skilled Senior Fullstack Engineer to join our team at Neurons. As a key member of our engineering team, you will play a critical role in developing and maintaining our advanced web platform.Key ResponsibilitiesTake ownership of the web platform's frontend codebase and libraries, defining and implementing new features...


  • Taastrup, Høje-Taastrup Kommune, Denmark NEURONS INC. ApS Full time

    About the RoleWe are seeking a highly skilled Senior Fullstack Engineer to join our team at Neurons Inc. ApS. As a key member of our engineering team, you will play a critical role in developing and maintaining our advanced web platform.Key ResponsibilitiesTake ownership of the web platform's frontend codebase and libraries, defining and implementing new...


  • Taastrup, Høje-Taastrup Kommune, Denmark ALD Automotive Full time

    Be part of a dynamic team shaping the future of ALD AutomotiveAs Senior Software Engineer, you will be instrumental in designing and developing our IT solutions, ensuring they meet the highest standards of functionality, stability, and quality.Your key responsibilities will include:Design and develop innovative IT solutions, collaborating with...


  • Taastrup, Høje-Taastrup Kommune, Denmark GlobalConnect AS Full time

    Are you skilled at transforming financial data into actionable insights? GlobalConnect is seeking a talented Finance Data Insights Specialist to join our team in Copenhagen, Oslo, or Stockholm. As a key member of our financial data operations, you will design, develop, and maintain robust financial models and reporting mechanisms that translate complex...


  • Taastrup, Høje-Taastrup Kommune, Denmark Nordea Full time

    About the RoleWe are seeking a highly skilled Data Warehouse Information Specialist to join our Common Data Warehouse team at Nordea. As a key member of our team, you will play a crucial role in supporting and delivering business development activities and data analysis to all business areas of the Nordea group.Key ResponsibilitiesWork as a business solution...


  • Taastrup, Høje-Taastrup Kommune, Denmark Nordea Full time

    About the RoleWe are seeking a highly skilled Senior Business Analyst to join our Master Data Governance and Analytics team. As a key member of our team, you will be responsible for providing expert-level support in establishing and maintaining high-quality Master Data products.As a Senior Business Analyst, you will work closely with our data professionals...


  • Taastrup, Høje-Taastrup Kommune, Denmark Parsons Corporation Full time

    About the RoleWe are seeking an experienced Infrastructure Operations Specialist to join our Critical Infrastructure team in the Copenhagen area.Key ResponsibilitiesProvide hands-on support for our UTO system landscape, ensuring seamless operation and maintenance of our critical infrastructure.Collaborate with our teams to identify and resolve technical...


  • Taastrup, Høje-Taastrup Kommune, Denmark Nordea Full time

    About the RoleWe are seeking a skilled Data Warehouse Information Specialist to join our team at Nordea. This role will involve working with a wide range of data-related topics and projects of high importance to the company.As a Data Warehouse Information Specialist, you will be responsible for interacting with stakeholders across different business areas...


  • Taastrup, Høje-Taastrup Kommune, Denmark Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Senior Enterprise Business Development Professional to join our dynamic and diverse team in the Transformational Office within the External Supply department.Key ResponsibilitiesPlan, manage, and implement strategic initiatives and projects in line with the External Supply strategy.Identify and pursue...


  • Taastrup, Høje-Taastrup Kommune, Denmark ALD Automotive Full time

    Join ALD Automotive as a 1st Line Risk Specialist and contribute to shaping our compliance culture and risk management practices.As a key member of our team, you will be responsible for identifying and assessing risks, developing strategies to mitigate them, and ensuring compliance with our global policies and procedures.Key Responsibilities:Risk screening...