Senior Manager, QA GCP PV

1 week ago

Copenhagen, Copenhagen, Denmark Genmab Full time

About the Role

Genmab is seeking a highly motivated Quality Assurance Manager to join our team. As a key member of our QA team, you will be responsible for ensuring the highest level of quality and compliance in our clinical trials.

Key Responsibilities

  • Plan, conduct, and report quality audits within the GCP regulated areas.
  • Mentor and train QA colleagues and lead auditors to increase the competency level across the global QA team.
  • Develop and maintain audit strategies in collaboration with the Team Lead.
  • Coordinate and lead GCP inspection readiness activities for FDA, EMA, and PMDA inspections.
  • Participate in inspections and audits performed by our partners.
  • Contribute to the development, maintenance, and improvement of the Genmab Quality Management System (QMS) with a focus on GCP and GCLP requirements.

Requirements

  • MSc in Natural Science or similar and at least 5 years of 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.

About You

  • You are passionate about Genmab's 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 and 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.

Locations

Genmab leverages the effectiveness of an agile working environment to promote employee work-life balance. Our offices are designed as open, community-based spaces that connect employees while being immersed in state-of-the-art laboratories.

  • Senior Manager, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly motivated QA Senior Manager to join our team at Genmab. As a QA Senior Manager, you will be responsible for ensuring the quality and compliance of our clinical trials and development processes.Key ResponsibilitiesRepresent QA GCP in the Clinical Development Process Expert Group (PEG) and in the Regulatory Registration...

  • Senior Manager, QA GCP/PV Lead

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionThe RoleGenmab is seeking a skilled and experienced QA Senior Manager to join our team. As a key member of our Quality Assurance group, you will be responsible for ensuring the highest standards of quality and compliance in our clinical development programs.About the RoleYou will represent QA GCP in the Clinical Development Process Expert...

  • Senior Manager, QA GCP/PV Lead

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will play a key role in ensuring clinical compliance within our QMS and will be responsible for the structure and hosting scheme of the GCP and PV mailboxes.Key Responsibilities:*...

  • Senior Manager QA GCP/PV Lead

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    The Genmab Team Awaits Your ExpertiseWe are seeking a highly skilled QA Senior Manager to join our team at Genmab, a company dedicated to transforming the lives of patients through innovative cancer treatment. As a key member of our Clinical Development Process Expert Group, you will play a vital role in ensuring the quality and compliance of our clinical...

  • Senior Manager, QA GCP/PV Lead

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly motivated QA Senior Manager to join our team. As a key member of our Clinical Development Process Expert Group, you will play a crucial role in ensuring the quality and compliance of our clinical and regulatory processes.Key ResponsibilitiesRepresent QA GCP in the Clinical Development Process Expert Group and...

  • Senior Manager, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly motivated and experienced Senior Manager to lead our Quality Assurance (QA) team in GCP and PV. As a key member of our global QA team, you will be responsible for planning, conducting, and reporting quality audits within the GCP regulated areas.Key ResponsibilitiesDevelop and maintain audit strategies in collaboration...

  • Senior Manager, QA GCP/PV Lead

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Job Title: Senior Manager, QA GCP/PVThe Role Are you inspired to work in a company with ambitious goals, exciting clinical development programs, and highly enthusiastic colleagues? Our vision by is that Genmab's knock-your-socks-off "KYSO" antibody medicines will transform the lives of people with cancer and other serious diseases. Do you want to safeguard...

  • Senior Director, QA GCP/PV

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionAt Genmab, we are dedicated to creating extraordinary futures by developing innovative antibody products and pioneering therapies that revolutionize cancer treatment and serious diseases.OverviewWe are seeking a highly motivated and experienced QA PV Associate Director to join our team. As a key member of our quality assurance department, you...

  • Senior Manager, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.Key Responsibilities:Plan, conduct, report, and follow...

  • Senior Manager, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.Key Responsibilities:Plan, conduct, report, and follow...

  • Senior Manager, QA GCP/PV

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development.Key Responsibilities:Plan, conduct, report, and follow...

  • Senior Manager, QA GCP

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Job Title: Senior QA Manager, GCP DivisionAbout the Role:We are seeking a highly motivated Senior QA Manager to join our GCP Division. As a Senior QA Manager, you will be responsible for ensuring the quality and compliance of our clinical trials. You will work closely with cross-functional teams to identify and address quality issues, develop and implement...

  • Senior Manager, QA GCP/PV

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly motivated QA Senior Manager to join our team at Genmab. This is an excellent opportunity to work in a dynamic and innovative company with a strong focus on quality assurance and regulatory compliance.Key ResponsibilitiesLead quality audits within the GCP regulated areas, ensuring compliance with regulatory...

  • Senior Manager, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly motivated and experienced Quality Assurance Senior Manager to join our team at Genmab. As a key member of our Quality Assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical development programs.Key ResponsibilitiesDevelop and implement quality audit strategies...

  • Senior Manager, Quality Assurance GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    The RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab. As a QA Senior Manager, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to clinical development. You will be able to combine your strong project...

  • Senior Manager, Quality Assurance GCP/PV Leader

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    Role OverviewGenmab is seeking a highly motivated QA Senior Manager with a strong background in GCP and GCLP to safeguard patients and ensure quality compliance in all aspects within GCP.Key Responsibilities Represent QA GCP in the Clinical Development Process Expert Group (PEG) and in the Regulatory Registration PEG. Lead the SOP QA review process to...

  • Associate Director, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking a highly motivated and experienced QA PV Associate Director to join our team. As a key member of our Quality Assurance team, you will be responsible for ensuring the quality and compliance of our Pharmacovigilance activities.Key ResponsibilitiesPlan, conduct, report, and follow up on quality audits within the PV regulated...

  • Associate Director, QA GCP/PV

    4 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.QA PV Associate DirectorWe're seeking a highly motivated QA PV Associate Director with at least 6 years of experience in auditing...

  • Associate Director, QA GCP/PV

    3 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.Quality Assurance RoleWe're seeking a highly motivated QA PV Associate Director with at least 6 years of experience in auditing PV...

  • Quality Assurance Manager with Expertise in GCP and GCLP

    2 weeks ago

    Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleThe RoleWe are seeking a highly motivated QA Senior Manager with at least 5 years of experience within GCP and/or GCLP to join our team at Genmab.This is a unique opportunity to work in a dynamic company with ambitious goals and exciting clinical development programs.As a QA Senior Manager, you will be responsible for ensuring clinical...