Manager, QA GMP

1 week ago

København, Denmark Genmab Full time

At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role & Department
With a clear strategy of becoming an integrated end-to-end biotech innovation powerhouse, Genmab recently started to market and sell their own products within cancer treatment. Expanding its focus to also being directly vested in the commercialization of the company’s products, we are now looking to further strengthen the QA Commercial & Life Cycle team located in Denmark and the United States.

As GMP QA Manager you will be a part of the well-functioning QA Commercial & Life Cycle team, with responsibility for quality oversight of starting materials, intermediates, and drug substances for commercial products. You will have a close collaboration with our Contract Manufacturing Organizations (CMOs)/Partners and process- and QC SMEs internally at Genmab.

This position will be located in DK, reporting to the Director of QA GMP Commercial & Life Cycle (located in DK). The Global QA Department has 50+ employees supporting GxP activities and located in Denmark, the US and Japan.

Responsibilities & Task

  • Maintaining and continuously improving Genmab’s Pharmaceutical Quality System to ensure compliance with EU and US regulations.
  • Gaining and maintaining knowledge on new/updated GMP/GDP-regulations and guidelines.
  • Handling of Deviations, CAPAs and Change Control in compliance with Genmab SOPs and applicable regulatory requirements.
  • Act as Delegated QP for the release of commercial products (Biological Intermediates, Chemical Intermediates and Drug Substance).
  • Reviewing and authoring of QMS SOPs, Work Instructions and other documents, as needed.
  • Supporting Quality Management Review and Annual Product Review.
  • Performing QA activities in relation to US market release in close cooperation with the global QA GMP team, Genmab’s CMOs, contract acceptors and Partners.
  • Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review and negotiation of Quality Agreements.
  • Representing QA GMP in project groups to advise on GMP compliance.
  • Participating in internal audits and regulatory inspections performed by various Health Authorities.
  • Train QA colleagues and stakeholders in relevant GMP topics.
  • Promote collaborative relations with relevant internal stakeholders, partners and CMOs.

Requirements

  • You hold a Master’s degree or equivalent in a relevant life science subject.
  • You have 5+ years experience within the pharmaceutical industry within QA.
  • Experience with biological and chemical GMP production.
  • Experience with CMO collaboration.
  • Experience with audits/inspections.
  • QP/delegated QP experience.

Moreover, it is expected that you have the following:

  • You have excellent interpersonal skills, problem-solving skills, communication skills in English, and a collaborative attitude.
  • As a person you enjoy a fast-paced and changing environment.
  • You are results and goal-oriented and committed to contributing to the overall success of Genmab.
  • Pragmatic and yet with attention to the necessary details.
  • Clear and persistent in your communication, expectations, and requirements to quality.

About You

  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
  • You are a generous collaborator who can work in teams with diverse backgrounds.
  • You are determined to do and be your best and take pride in enabling the best work of others on the team.
  • You are not afraid to grapple with the unknown and be innovative.
  • You have experience working in a fast-growing, dynamic company (or a strong desire to).
  • You work hard and are not afraid to have a little fun while you do so.

Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Location: Copenhagen - Carl Jacobsens Vej 30

#J-18808-Ljbffr

  • QA Specialist or Professional for Development GMP activities

    1 week ago

    København, Denmark Ascendis Pharma AS Full time

    Passionate about Quality Assurance with expertise within outsourced GMP activities and development projects? Ascendis Pharma invites you to explore the role of our newest QA Specialist / QA Professional for Development GMP activities. With roots spanning Denmark, Germany, and the United States, Ascendis Pharma A/S emerges as an innovative and dynamic...

  • QA Lean Partner

    3 weeks ago

    København, Denmark Aj Vaccines AS Full time

    We are offering an unique opportunity for an innovative QA LEAN Partner to establish and develop a new role within our Quality Assurance department. In this position, you will have the freedom to shape and define this role from the ground up, working closely with senior leadership to influence the direction of quality assurance processes. Reporting directly...

  • QA Lean Partner

    1 week ago

    København, Denmark AJ Vaccines Full time

    We are offering a unique opportunity for an innovative QA LEAN Partner to establish and develop a new role within our Quality Assurance department. In this position, you will have the freedom to shape and define this role from the ground up, working closely with senior leadership to influence the direction of quality assurance processes. Reporting directly...

  • Scientist, QA Manufacturing Support

    4 days ago

    København, Denmark AGC Inc Full time

    Scientist, QA Manufacturing Support Apply locations: Copenhagen, Denmark Time type: Full time Posted on: Posted 29 Days Ago Job requisition id: JR100828 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...

  • QA and Validation Engineer Denmark Copenhagen

    1 week ago

    København, Denmark DIS - CREADIS Engineering Solutions & Consulting Full time

    We are experiencing significant growth and are seeking additional colleagues to focus on QA and validation tasks for a wide range of customers within the life science industry. Together with skilled colleagues, you will take part in the exciting journey! Your Role in Future Projects As an employee at DIS, you will become part of an ambitious environment...

  • QA/QC Manager

    1 week ago

    København, Denmark QMC Telecom International Full time

    Overall Role Objective We have an exciting opportunity for a QA QC Manager to join Suir Engineering Ltd. The position will be based on a Data Centre project in Denmark.Here in Suir Engineering we are a leading international provider of innovative Mechanical, Electrical and Instrumentation Engineering Solutions. Our core sectors are Energy, Power and...

  • Product Owner for QA Strategy and Engagements

    1 week ago

    København, Denmark Danske Bank Full time

    The Developer Experience tribe offers an exciting opportunity to make a meaningful impact on the productivity and satisfaction of developers here at Danske Bank. We are seeking an experienced and dynamic Product Owner and Quality Assurance (QA) SME to join our soon to be established QA Strategy and Engagements squad. As we aim to establish a new squad...

  • Group RP Manager

    1 month ago

    København V, Denmark ABACUS MEDICINE AS Full time

    Join Abacus Medicine Group as our new Group RP Manager, where you'll lead a dynamic global team, ensure quality excellence in EU medicinal product supply, and travel regularly to our locations worldwide. Based in our Copenhagen HQ, this role offers a unique opportunity to make a significant impact in the pharmaceutical industry.About the Role: As our new...

  • Group RP Manager

    1 month ago

    København V, Denmark ABACUS MEDICINE AS Full time

    Join Abacus Medicine Group as our new Group RP Manager, where you'll lead a dynamic global team, ensure quality excellence in EU medicinal product supply, and travel regularly to our locations worldwide. Based in our Copenhagen HQ, this role offers a unique opportunity to make a significant impact in the pharmaceutical industry.About the Role: As our new...

  • Senior QA Engineer

    1 week ago

    København, Denmark Shape Full time

    BECOME A PART OF THE TEAM Shape is an award-winning app-focused digital product studio based in Copenhagen, Denmark. We’re dedicated to making outstanding apps for prominent clients such as OK, PureGym, Nordisk Film, Bolius, TV2 Regions, Solar, Magasin, RedBull, Mofibo, and Aarstiderne. We are proud that our work is touched, tapped, swiped, and pinched by...

  • Senior QA Engineer

    1 week ago

    København, Denmark Teracloud Denmark Full time

    About the Role: Teracloud is a global software product company with a wide range of product lines from industrial power, e-sports platforms, climate controllers, and software products. VMS Software, Inc. is an enterprise software company with offices around the world. Our company develops, sells, and supports innovative and advanced releases of OpenVMS, the...

  • Senior Manager, QA GCP/PV

    4 months ago

    København V, Denmark Genmab Full time

    At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...

  • Senior QA Engineer

    1 week ago

    København, Denmark Shape Aps Full time

    BECOME A PART OF THE TEAM Shape is an award-winning app-focused digital product studio based in Copenhagen, Denmark. We’re dedicated to making outstanding apps for prominent clients such as OK, PureGym, Nordisk Film, Bolius, TV2 Regions, Solar, Magasin, RedBull, Mofibo, and Aarstiderne. We are proud that our work is touched, tapped, swiped, and pinched by...

  • Senior QA Engineer

    1 week ago

    København, Denmark SHAPE AS Full time

    BECOME A PART OF THE TEAM Shape is an award-winning app-focused digital product studio based in Copenhagen, Denmark. We’re dedicated to making outstanding apps for prominent clients such as OK, PureGym, Nordisk Film, Bolius, TV2 Regions, Solar, Magasin, RedBull, Mofibo, and Aarstiderne. We are proud that our work is touched, tapped, swiped, and pinched by...

  • Senior QA Engineer

    1 week ago

    København, Denmark The HubDanske Bank Full time

    BECOME A PART OF THE TEAM Shape is an award-winning app-focused digital product studio based in Copenhagen, Denmark. We’re dedicated to making outstanding apps for prominent clients such as OK, PureGym, Nordisk Film, Bolius, TV2 Regions, Solar, Magasin, RedBull, Mofibo, and Aarstiderne. We are proud that our work is touched, tapped, swiped, and pinched by...

  • Senior Manager, QA GCP/PV

    1 week ago

    København, Denmark Genmab Full time

    At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being...

  • Associate Director

    4 weeks ago

    København, Denmark Ortolan Group Full time

    Associate Director EU Batch Release - QP and RPHybrid role: based in Copenhagen, Denmark (3 days office, 2 days home)Salary: Competitive + Benefits + BonusIf you are an agile, committed, and strategic quality professional, with experience of leading QA teams and eligibility as QP and RP, then we want to hear from you!Join us to help improve peoples' lives...

  • Associate Director

    1 week ago

    København, Denmark Ortolan Full time

    Associate Director EU Batch Release - QP and RP Hybrid role: based in Copenhagen, Denmark (3 days office, 2 days home) Salary: Competitive + Benefits + Bonus If you are an agile, committed, and strategic quality professional, with experience of leading QA teams and eligibility as QP and RP, then we want to hear from you! Join us to help improve peoples'...

  • Medical device QA/RA specialist

    1 week ago

    København, Denmark Radiobotics Full time

    Do you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with every part of a QMS system. Maybe you are a seasoned QA specialist that would like to...

  • Medical device QA/RA Consultant

    1 month ago

    København, Denmark Radiobotics ApS Full time

    This is a temporary consultancy position to support while we search for a permanent hireDo you have a flair for product quality? And are you curious to see if you can put your QA/RA experience to work and place our products in new markets? Maybe you have been working with product registrations for a while and now you would like to work more holistically with...