Quality Assurance Director for Pharmacovigilance

1 week ago


Copenhagen, Copenhagen, Denmark Genmab Full time

At Genmab, we're dedicated to building extraordinary futures together. We develop innovative antibody products and pioneer groundbreaking therapies that transform the lives of patients and change the future of cancer treatment and serious diseases.

Overview

We're seeking a highly motivated Quality Assurance Director for Pharmacovigilance with at least 6 years of experience in auditing PV activities. You'll be responsible for planning, conducting, reporting, and following up on quality audits within the PV regulated areas. Your expertise will drive the PV audit strategy and plan in collaboration with senior QA PV colleagues.

About the Role

  • You'll lead PV inspections readiness activities, partner audits, and GCP inspection readiness for FDA, EMA, and PMDA inspections.
  • You'll represent QA in the PV and Medical Affairs Process Expert Group.
  • You'll participate in inspections and audits performed by partners and deliver PV advisory expertise within the company and to external vendors.

Your Profile

  • MSc in Natural Science or similar, with at least 6 years of profound experience within auditing of Pharmacovigilance activities.
  • Experienced Lead Auditor within PV, preferably with in-depth knowledge related to outsourced safety processes and internal safety processes.

This role is located in Denmark, offering on-site presence combined with remote work options. As our ideal candidate, you'll bring strong analytical skills, strategic thinking, and excellent communication skills to this dynamic team.

About Our Company

Genmab leverages an agile working environment to promote employee work-life balance. Our collaborative office spaces connect employees while being immersed in state-of-the-art laboratories. Whether in-office or remote, we prioritize connecting with each other to innovate and excel.

Location: Denmark

Estimated salary: €85,000 - €110,000 per year, depending on experience.



  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly experienced Senior Quality Assurance Director to lead our Pharmacovigilance team. As a key member of our quality assurance department, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in all aspects of PV activities.


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    {"Job SummaryWe are seeking a highly motivated Senior Quality Assurance Director, Pharmacovigilance to join our team at Genmab. In this role, you will be responsible for ensuring the quality and compliance of our pharmacovigilance activities.Key Responsibilities* Plan, conduct, report, and follow up on quality audits within the pharmacovigilance regulated...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we strive to push the boundaries of innovation in cancer treatment and serious diseases. We're looking for a highly motivated and experienced QA PV Associate Director to join our team.As a QA Associate Director, you will have in-depth scientific expertise within quality assurance and all regulatory requirements related to Pharmacovigilance...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking a highly motivated and experienced Pharmacovigilance Quality Assurance Director to join our team at Genmab. This role is located in Denmark, with the option to work remotely a few days a week.Job DescriptionThe successful candidate will be responsible for planning, conducting, reporting, and following up on quality audits within...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Transforming lives through innovative cancer treatments is at the heart of Genmab's mission. As a Quality Assurance Associate Director, you'll play a pivotal role in upholding the highest standards of quality and compliance within Pharmacovigilance.About the RoleWe're seeking a highly motivated and experienced individual to lead our Pharmacovigilance Quality...


  • 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. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced Strategic QA Director to lead our global Pharmacovigilance (PV) team. As a key member of our Quality Assurance department, you will be responsible for ensuring compliance with regulatory requirements and driving quality excellence in PV activities.Responsibilities:Develop and implement PV audit strategies and plans...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is committed to pushing the boundaries of antibody product development and pioneering therapies that transform the lives of patients with cancer and serious diseases.About the RoleWe are seeking a highly motivated Senior Quality Assurance Lead with at least 6 years of experience in auditing Pharmacovigilance activities. The ideal candidate will have a...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is a global biotech leader in the development of antibody products and pioneering therapies. We are committed to safeguarding patients and ensuring quality compliance in all aspects within Pharmacovigilance.About the Role:We are seeking a highly motivated Senior Quality Assurance Lead with at least 6 years of experience in auditing PV activities. As...


  • Copenhagen, Copenhagen, Denmark National Oilwell Varco Denmark IS Full time

    Job Title: Director, QualityAbout the Role:We are seeking a highly experienced and strategic Director of Quality to lead our global quality assurance and quality control initiatives in Subsea Production Systems. The successful candidate will drive the quality agenda across all levels of the organization, ensuring the integrity, reliability, and performance...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About GenmabGenmab is committed to pushing the boundaries of cancer treatment and transforming lives through innovative antibody products.SalaryWe offer an attractive salary package, estimated at €120,000 - €150,000 per annum, commensurate with experience, for this challenging role based in Denmark.Job DescriptionThe ideal candidate will be responsible...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionGenmab is seeking a highly experienced Quality Assurance (QA) professional to join our Late Stage Development team in Denmark. As a Senior Quality Assurance Director, you will be responsible for setting the quality direction for Genmab's Late Stage Development products and ensuring compliance to industry standards and regulations.Key...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures through the development of innovative 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...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    OverviewGenmab is a pioneering biotechnology company dedicated to developing innovative cancer treatments. We are seeking a highly skilled Quality Assurance Director to join our team and contribute to our mission of transforming patients' lives.Job SummaryWe are looking for a seasoned QA professional with at least 5 years of experience in GCP and/or GCLP to...


  • Copenhagen, Copenhagen, Denmark Pandora Full time

    About the Opportunity:Pandora is seeking an experienced Quality Engineering and Assurance Director to lead our quality engineering and assurance teams within a dynamic people-centric environment at the Pandora Digital Hub.The ideal candidate will have a proven track record in overseeing quality across e-commerce platforms, retail store technology, and order...


  • Copenhagen, Copenhagen, Denmark MeetFrank Full time

    About the RoleWe are seeking an experienced Associate Director to lead our IT Quality Assurance team in ensuring the regulatory compliance and operational excellence of our computerized systems.Key ResponsibilitiesLead QA processes for AI and emerging technologies, ensuring adherence to internal standards and external regulations.Oversee system validation,...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Genmab is seeking a highly motivated Director of Quality Assurance GCP and PV to join our global QA team. This role offers the opportunity to work in a fast-paced, dynamic environment with a talented team of professionals dedicated to delivering high-quality products.About the RoleThis position will lead the development and implementation of quality...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Lundbeck offers an exciting opportunity to work in a dynamic environment, where you will play a key role in driving standardization and process improvements for the company's CMOs.As a Pharmaceutical Quality Assurance Specialist, you will be responsible for supporting the release and daily operation of the CMO cell at Lundbeck, ensuring the quality level is...


  • 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...


  • 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...