QA Director

2 weeks ago


Copenhagen, Copenhagen, Denmark Genmab Full time
Company Overview

Genmab is a global biotech company dedicated to transforming the lives of patients through innovative cancer treatment.

Salary and Benefits

We offer a highly competitive salary, ranging from $150,000 to $180,000 annually, depending on experience. Our benefits package includes health insurance, retirement plans, and generous paid time off.

About the Role

The QA Director will play a critical role in ensuring compliance with industry standards and regulations for Genmab's Late Stage Development products. As GMP QA Associate Director, you will be responsible for setting the quality direction for our team and collaborating with cross-functional partners to achieve business objectives.

  • Act as QA responsible for Manufacturing, Process Transfer, Process Validation for Antibody Intermediates, Chemical Intermediate, and Drug Substance ADC.
  • Act as QP delegate by releasing Antibody Intermediates, Chemical Intermediates, and Drug Substance ADC for further manufacturing.
  • Provide QA oversight of CMOs in relation to outsourced GMP activities, including Audits, Vendor Risk Evaluations, review, and negotiation of Quality Agreements.
Required Skills and Qualifications

To succeed in this role, you will need:

  • A MSc degree or equivalent in a relevant life science subject.
  • +10 years of experience from the pharmaceutical industry within QA, preferably within biologics and/or chemical intermediate, and/or sterile products.
  • Experience working in an EDMS system.
  • Excellent communication skills in English, and a collaborative mindset.
Benefits

At Genmab, we value our employees' well-being and offer a range of benefits, including:

  • Flexible work arrangements, including remote work options.
  • Opportunities for professional growth and development.
  • A diverse and inclusive work environment.
Location

Our offices are designed as open, community-based spaces that foster collaboration and innovation. We leverage the effectiveness of an agile working environment for the betterment of employee work-life balance.



  • 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

    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...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QALundbeck is seeking an experienced Senior Vendor Specialist to lead the CMC Development QA vendor management program. As a key member of the QA team, you will be responsible for ensuring the compliance and quality of our vendors, supporting the development of new innovative treatments for brain diseases, and...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior QA Specialist for CMC DevelopmentThis is a unique opportunity to lead the QA of the Lundbeck CMC vendor management program while contributing to the development of innovative treatments for brain diseases.We offer an exciting job with a broad variety in your daily work ensuring compliant vendor oversight of Lundbeck CMOs for clinical trials. CMC...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QAAs a key member of our CMC Development QA team, you will play a crucial role in driving the continuous development of our vendor management program. This includes training colleagues, ensuring compliant vendor oversight of our CMOs for clinical trials, and supporting our current pipeline from early stage to late...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Senior Vendor Specialist, CMC Development QALundbeck is seeking a highly skilled Senior Vendor Specialist to lead the CMC vendor management program. As the QA lead, you will drive the continuous development of the program, including training of colleagues, and ensure compliant vendor oversight of Lundbeck CMOs for clinical trials.Key ResponsibilitiesQA owner...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleWe are seeking an experienced Pharmacovigilance Assurance Director to join our team at Genmab. This is a fantastic opportunity for a motivated professional to lead quality audits, develop and improve audit strategies, and mentor QA colleagues in GCP and PV.Job DescriptionThe successful candidate will plan, conduct, report, and follow up on...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the RoleGenmab is seeking an experienced Director of Quality Assurance, GCP/PV to join our team. As a key member of our QA function, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in all aspects of our clinical development process.This role can be located in Copenhagen, Denmark, or...


  • 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 Lundbeck Full time

    At Lundbeck, we are seeking an experienced QA Specialist to lead our vendor management program in CMC Development. As a key member of our team, you will play a crucial role in ensuring compliant vendor oversight of our Contract Manufacturing Organizations (CMOs) for clinical trials.We offer an exciting opportunity to work with a broad range of tasks,...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Role SummaryLundbeck seeks a highly skilled GMP/GDP Auditor to join its CMC Development QA team. As a key member of this team, you will play a vital role in ensuring the quality and compliance of our CMC vendors.Key ResponsibilitiesConduct external audits of CMC vendors to ensure compliance with GMP/GDP regulationsLead internal audits of CMC to identify...


  • 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 Genmab Full time

    About the RoleAt Genmab, we are seeking a highly skilled and experienced Senior Biotechnology QA Manager to join our team in Copenhagen. This is an excellent opportunity for a results-driven professional to take on a challenging role and contribute to the success of our organization.This position will report directly to the Director of QA GMP Commercial &...


  • 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 Lundbeck Full time

    Senior Vendor Specialist, CMC Development QA ProfessionalWe are seeking an experienced Senior Vendor Specialist to join our CMC Development QA team. As a Senior Vendor Specialist, you will be responsible for ensuring the quality and compliance of our vendors, driving the continuous development of our vendor management program, and leading audits and vendor...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    Role OverviewWe are seeking a skilled Senior Vendor Specialist to join our CMC Development team as a QA lead for the vendor management program. This is a great opportunity to contribute to the development of new innovative treatments for brain diseases while driving the continuous improvement of our vendor management program.About the JobAs a Senior Vendor...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    About LundbeckLundbeck is a global pharmaceutical company with a rich history of developing innovative treatments for brain diseases. Our mission is to bring life-changing therapies to patients in need.Job OverviewWe are seeking a highly skilled Senior Vendor Specialist to join our CMC Development QA team. This is an exciting opportunity to work on the...


  • Copenhagen, Copenhagen, Denmark Lundbeck Full time

    About LundbeckLundbeck is a global biopharmaceutical company that specializes in the development and manufacturing of innovative treatments for brain diseases. Our mission is to make a meaningful difference in the lives of patients by developing and delivering novel therapies that address unmet medical needs.Job SummaryWe are seeking a Senior QP Delegate to...


  • 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

    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...