Current jobs related to Regulatory Compliance Expert QC - Gladsaxe, Gladsaxe Municipality - AGC Biologics

  • Regulatory Compliance Coordinator

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Key ResponsibilitiesRepresent QC Chemistry in Customer project teams and internal AGC QC analytical teamsCoordinate and plan analytical QC activities, ensuring timely completion of projects and tasksSupport clinical and commercial manufacturing for our Customers worldwide, maintaining close relationships with internal stakeholders and external vendorsDevelop...

  • Regulatory Compliance Expert

    7 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    What We OfferWe offer a dynamic and supportive work environment, where you will have the opportunity to work with a talented team of professionals.As a Regulatory Compliance Expert at Novo Nordisk A/S, you will have access to training and development opportunities, and the chance to make a real difference in the lives of patients through the development of...

  • QC Operations Manager

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionWe are seeking a highly motivated and organized QC Coordinator to join our team at AGC Biologics. The successful candidate will be responsible for coordinating and planning analytical QC activities, supporting clinical and commercial manufacturing for our Customers worldwide.This role requires expertise in analytical chemistry, including HPLC,...

  • Leadership Role in QC Bioassay

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job SummaryAGC Biologics is seeking a seasoned professional to fill the role of Manager in QC Bioassay. As a member of our team, you will be responsible for creating a positive and inspiring work environment, fostering a culture of excellence, and driving results-oriented initiatives.The ideal candidate will have a strong background in life sciences and...

  • Regulatory Compliance Expert

    6 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    About Our TeamWe are a diverse and inclusive team of professionals dedicated to delivering high-quality products and services. Our team is passionate about innovation and quality, and we are committed to creating a culture of excellence.We are seeking a Senior Quality Assurance Specialist to join our CMC API QA team. In this role, you will be responsible for...

  • QC Bioassay Manager Position

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewWe are seeking a highly skilled Manager in QC Bioassay to lead our team of Scientists and Technicians. As a seasoned professional, you will be responsible for creating a positive and inspiring work environment, fostering a culture of excellence, and driving results-oriented initiatives.The successful candidate will report directly to the Director...

  • Quality Control Stability Expert

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a temporary Quality Control Stability Expert to join our QC Stability Team at AGC Biologics. This is a one-year position that involves collaborating with stakeholders to ensure the success of stability studies.The role requires strong analytical skills, attention to detail, and excellent communication abilities. As a member of...

  • QC Bioassay Expert

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About AGC BiologicsWe are a global CDMO organization specializing in the development of biopharmaceutical manufacturing processes and GMP manufacturing of biopharmaceutical proteins for both clinical testing and marketing.Company OverviewOur company was established with the aim of providing innovative solutions for the biopharmaceutical industry.QC Bioassay...

  • QC Coordinator

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.Are you motivated by leading and participating in coordination and planning...

  • Manager in QC Bioassay

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Role and ResponsibilitiesAs Manager in QC Bioassay you are managing a team of both Scientists and Technicians. You naturally create a positive and inspiring environment around you and lead by being the good example. You thrive in a fast-paced environment and have focus on delivery of results right and on time, but at the same time have focus on your...

  • Quality Control Analyst

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionYou will be a key member of the QC Stability Team, contributing to the stability studies of Drug Substance, Drug Product, Placebo, and Reference Material. Your primary responsibility will be to work closely with stakeholders such as customers, project managers, management, your own department, and QA to identify and manage analytical stability...

  • Raw Materials Quality Assurance Expert

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    About the RoleWe are seeking a skilled professional to join our QC Raw Materials team as a quality assurance expert. This individual will be responsible for ensuring the highest standards of quality in raw material samples and play a critical role in maintaining our reputation for excellence.Main ResponsibilitiesSampling and testing raw materials to meet...

  • QC Technician for QC Raw Materials Team

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.The PositionYou will be a part of the QC Raw Materials Team which, together...

  • Quality Assurance Manager QC Chemistry

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job DescriptionThis is an exciting opportunity to join our Quality Control department as Manager of QC Chemistry HPLC Scientists. In this role, you will lead and develop a team of dedicated scientists, working closely with colleagues from across the organization.You will be responsible for ensuring that all analytical testing and method validations are...

  • R&D Compliance Expert

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Job DescriptionThe Quality & Compliance Partner will take part in overseeing Quality & Compliance initiatives related to Data Governance, ensuring adherence to Data Privacy regulations, and collaborating with cross-functional teams to optimize Data Practices. This role involves driving initiatives that support the process for identification, assessment, and...

  • QC Professional

    5 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Job OverviewThis temporary Quality Control Stability position at AGC Biologics offers an exciting opportunity to work with a talented team in a dynamic environment. As a member of our QC Stability Team, you will contribute to the success of stability studies by analyzing data, preparing reports, and collaborating with stakeholders.The ideal candidate will...

  • Expert in Regulatory Affairs

    2 weeks ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create AlertExpert in Regulatory Affairs - Primary PackagingCategory: Reg Affairs & Safety PharmacovigilanceLocation:Søborg, Capital Region of Denmark, DKAre you ready to take on new challenges in primary packaging development across emerging therapeutic areas and innovative products? Would you like to use...

  • Regulatory Compliance Specialist

    4 days ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    Digital Health & Staffs Quality DepartmentOur department is responsible for ensuring the quality and integrity of our digital health products and processes. We are a collaborative and dynamic team that values innovation and continuous improvement. As a Senior QA Professional, you will play a critical role in helping us achieve our goals and objectives.Key...

  • QC Bioassay Senior Scientist

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

    Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients' lives by bringing new biopharmaceuticals to market.Are you looking for an exciting job in a fast-growing international CDMO...

  • QC Project Professional

    1 week ago

    Gladsaxe, Gladsaxe Municipality, Denmark Novo Nordisk AS Full time

    JobbeskrivelsePlacering Lyngby, DenmarkJobkategori Quality Ansøg nu Do you have experience in project management and knowledge about IT/OT in Quality Control (QC) laboratories? We are looking for a QC Project Professional to join our team in the Digital Data & IT Product Supply (DD&IT PS)– Fill & Finish Expansions department at Novo Nordisk.If you are...

Regulatory Compliance Expert QC

2 weeks ago

Gladsaxe, Gladsaxe Municipality, Denmark AGC Biologics Full time

At AGC Biologics A/S, we are committed to improving patients' lives by developing and manufacturing biopharmaceuticals. Our QC Bioassay team plays a vital role in this process, ensuring the quality and reliability of our products.

Key Responsibilities

The successful candidate will have the following responsibilities:

  • Review and approve analytical results from various methods
  • Conduct method validations according to current ICH guidelines
  • Participate in troubleshooting and scientific support on bioassay methods
  • Develop and maintain compliance documents related to QC activities

This is an excellent opportunity for a motivated and experienced Senior Scientist to join our team and contribute to the success of our organization.