Senior Manager, QA GCP/PV

2 days ago

Copenhagen, Copenhagen, 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
Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by 2030 is that Genmab's antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard patients and ensure quality compliance in all aspects within GCP? – Then seize this great career opportunity

We are looking for a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP. You are likely already an experienced lead auditor with the capabilities to train other auditors within GCP/GCLP. You are familiar with internal process audits and CRO audits of clinical data processing in different IT systems. You have a deep knowledge of the requirements related to computerized systems in clinical trials and you understand the impact.

As QA Senior Manager you will have in-depth and strong scientific expertise within quality assurance and all regulatory requirements related to clinical development. You will have strong analytical skills, high quality standards, and attention to detail as well as the ability to apply these qualities into a strategic context that enables you to identify solutions within agreed deadlines.

You will be working in a global team with QA colleagues located in the US, the Netherlands, Japan, and Denmark. Furthermore, you will be part of a strong cross-functional collaboration throughout the company.

Key responsibilities include:

  • You will plan, conduct, report and follow up on quality audits within the GCP regulated areas.
  • Mentor on-boarding QA colleagues as well as experienced Lead auditors to increase the competency level across the global QA GCP & PV team.
  • You will develop and maintain the audit strategies in collaboration with the Team Lead.
  • You will coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
  • You will participate in inspections and audits performed by our partners.
  • Participate in, or drive the development, maintenance, and improvement of the Genmab QMS with focus on GCP and GCLP requirements.
  • Conduct and coordinate internal GCP training.
  • Deliver GCP advisory expertise both within the company and to external vendors.

Requirements:

  • MSc in Natural Science or similar and at least 5 years of profound experience within GCP and GCLP.
  • Experienced Lead Auditor within GCP and/or GCLP, preferably with in-depth knowledge related to internal process audits and CRO audits of clinical data processing in different IT systems.
  • Practical proficiency in the use and understanding of Veeva Vault QMS.
  • Experience with the due diligence process and qualification of new vendors or services.
  • Considered to be a Domain Expert within GCP and/or GCLP by peers with a strong interest and ability to educate others.

Moreover, you meet the following personal requirements:

  • Strong analytical skills with an eye for detail combined with the ability to extract and apply into a tactical and strategic context.
  • To strive and thrive in a setting with multiple complex tasks and shifting priorities.
  • Pro-active and open-minded, a dedicated team player with excellent oral and written communication skills.

This role can be located in Copenhagen, Denmark, or Utrecht, the Netherlands, or Princeton, New Jersey, U.S.

The role is hybrid, with an expectation of 60% on-site presence, combined with the option to work remotely two days per week on average.

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.

Location: Copenhagen - Carl Jacobsens Vej 30

Additional locations:

  • Utrecht
  • Princeton, NJ
#J-18808-Ljbffr

  • GCP Senior Specialist

    2 days ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    We're Genmab, a biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. Our team is passionate about pushing boundaries and making a meaningful impact in the world.We're seeking a highly skilled QA Senior Manager to join our quality assurance team. As a seasoned expert in GCP and GCLP regulations, you'll...

  • Senior DevOps Engineer

    4 days ago

    Copenhagen, Copenhagen, Denmark Ønskeskyen Full time

    We are witnessing substantial growth with our innovative digital wish list application, and we need a Senior DevOps Engineer - GCP to refine our skills within our dynamic, cross-functional team. This position offers a fantastic opportunity to advance professionally in a forward-thinking environment.About UsAt Ønskeskyen / GoWish, we foster an energetic work...

  • Quality Assurance Lead

    2 days ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're driven to transform the lives of patients through innovative cancer treatments. Our team is passionate about pioneering therapies that make a meaningful difference in the world.We're seeking a highly motivated QA Senior Manager to join our global quality assurance team. As a seasoned expert in GCP and GCLP regulations, you'll play a key role...

  • Pharmacovigilance Senior Manager

    4 days ago

    Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Select how often (in days) to receive an alert: Create Alert Category: Reg Affairs & Safety Pharmacovigilance Location: Ørestad, Capital Region of Denmark, DK Are you passionate about ensuring patient safety and compliance in pharmacovigilance? Do you have a knack for strategic oversight and collaboration across international teams? We are looking for a...

  • Senior QA Engineer

    3 days ago

    Copenhagen, Copenhagen, 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 QA Engineer

    2 days ago

    Copenhagen, Copenhagen, 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...

  • IT Operations Manager

    23 hours ago

    Copenhagen, Copenhagen, Denmark Tampa Gardens Senior Living Full time

    As a DevOps Consultant at Tampa Gardens Senior Living, you will be responsible for designing, implementing, and maintaining our cloud infrastructure. This is an exciting opportunity to work with a talented team of professionals who share your passion for innovation and excellence.About the TeamWe're a dynamic and collaborative team, working together to...

  • DevOps Engineer, GCP

    3 hours ago

    Copenhagen, Copenhagen, Denmark Mouseflow Full time

    Mouseflow Copenhagen, Capital Region of Denmark, Denmark Mouseflow is growing rapidly, securing our position as a leading provider of digital- and user experience analytics for customers all around the world. For our HQ in the center of Copenhagen, we're now hiring an experienced DevOps Engineer to help us operate, monitor and maintain our large-scale hybrid...

  • Senior DevOps Expert

    23 hours ago

    Copenhagen, Copenhagen, Denmark Tampa Gardens Senior Living Full time

    At Tampa Gardens Senior Living, we're committed to providing the best possible care for our residents. To achieve this, we need a skilled DevOps Consultant to join our team.About the RoleWe're looking for a highly motivated and experienced DevOps Consultant to lead our cloud engineering efforts. As a key member of our IT team, you will be responsible for...

  • QA Senior Specialist for QC

    3 hours ago

    Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    Vi redder menneskeliv på verdensplan; Vil du være med? Hvis du brænder for at gøre en forskel og sikre kvaliteten af livsvigtige produkter, så er denne stilling måske noget for dig. Vi søger lige nu flere medarbejdere til vores afdeling. Som QA Senior Specialist i QA-afdelingen spiller du en afgørende rolle i vores mission og får mulighed for at...

  • QA Lean Partner

    2 days ago

    Copenhagen, Copenhagen, 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 Portfolio Manager

    23 hours ago

    Copenhagen, Copenhagen, Denmark Aj Vaccines AS Full time

    We are seeking an experienced QA Portfolio Manager to join our team at Aj Vaccines A/S. As a key member of our Quality Assurance department, you will be responsible for shaping and developing a new role that aligns with our strategic objectives.In this position, you will oversee the QA project portfolio, ensuring effective management and alignment with...

  • Senior Manager, Drug Safety and Pharmacovigilance

    14 hours ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    We are seeking a highly skilled (Senior) Manager, Safety Data Management, to join our Global Drug Safety and Pharmacovigilance (GDS&PV) unit. As a key member of our team, you will be responsible for configuring and maintaining safety systems, generating complex reports, and implementing and validating safety systems and solutions. Your expertise in safety...

  • QA Lean Partner

    2 days ago

    Copenhagen, Copenhagen, 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...

  • Regulatory Compliance Manager

    2 days ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is committed to delivering high-quality products and services that meet the needs of patients and healthcare professionals. We're looking for a skilled QA Senior Manager to lead our quality assurance efforts and ensure compliance with regulatory requirements.This is an exciting opportunity to join a dynamic team and contribute to our mission of...

  • Senior QA Project Manager for Master Data program

    1 day ago

    Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Category: Quality Location: Bagsværd, Capital Region of Denmark, DK Are you passionate about Quality and Master Data Management (MDM)? And are you motivated by leading or participating in large, cross-functional projects? We are looking for a Senior Quality Project Manager with strong master data competencies to join the newly established Project Office in...

  • Senior Data Management Specialist

    19 hours ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About UsAt 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. Our people are caring, candid, and impact-driven, and our business is innovative and rooted in science.The Job DescriptionThis role...

  • Senior Scientist, QA Mammalian

    2 days ago

    Copenhagen, Copenhagen, Denmark AGC Inc Full time

    Senior Scientist, QA Mammalian Senior Scientist, QA Mammalian Apply locations Copenhagen, Denmark time type Full time posted on Posted 4 Days Ago job requisition id JR101647 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...

  • Senior QA Professional

    5 days ago

    Copenhagen, Copenhagen, Denmark AJ Vaccines Full time

    We are seeking a Senior QA Professional to join our Quality Assurance department at AJ Vaccines. As a key member of our team, you will be responsible for leading cross-functional teams in the development and implementation of quality assurance processes and procedures.Key ResponsibilitiesQuality Management Systems: Develop and maintain quality management...

  • Senior QA/RA Expert for Radiobotics ApS

    23 hours ago

    Copenhagen, Copenhagen, Denmark Radiobotics ApS Full time

    About Senior QA/RA Expert for Radiobotics ApSWe are a dynamic and innovative company dedicated to solving the global need for radiologists while ensuring every patient receives expert-level care. Our vision is that all routine X-rays of the musculoskeletal system are augmented and first-line reported by our products.We are seeking a Senior QA/RA Expert to...