Quality Assurance Manager with Expertise in GCP and GCLP
2 weeks ago
The Role
We 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 compliance within our QMS and will have the opportunity to develop and maintain GCP and PV SOPs.
Key responsibilities include representing QA GCP in the Clinical Development Process Expert Group (PEG), leading the SOP QA review process, and ensuring transparency and overview of all clinical and regulatory SOPs.
You will also be responsible for conducting QA review and approval of clinical and regulatory SOPs, engaging QA colleagues in the QA review and approval process, and revising GCP/PV QA SOPs as needed.
Additionally, you will be responsible for writing GCP/PV QA relevant SOPs, conducting and coordinating internal GCP/GCLP training, and delivering GCP advisory expertise within the company and to external vendors.
This is a hybrid role 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 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 and are determined to do and be your best.
- You are not afraid to grapple with the unknown and be innovative and 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.
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.
-
Global GCP Quality Assurance Expert
7 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe Genmab Team is seeking a highly experienced and skilled Global GCP Quality Assurance Expert to join our QA team. The role offers an exciting opportunity to utilize your expertise in quality assurance, regulatory compliance, and audit management to drive the company's growth and success.About the RoleAs a key member of our QA team, you will be responsible...
-
Director of Quality Assurance GCP and PV
3 days ago
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab 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...
-
Senior Manager, Quality Assurance GCP/PV
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe 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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe are seeking a highly motivated and experienced Quality Assurance Manager to join our clinical development team at Genmab. As a Quality Assurance Manager, you will play a crucial role in ensuring the quality of our clinical trials and maintaining compliance with regulatory requirements.The ideal candidate will have at least 5 years of experience...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeUnlock a challenging opportunity to lead quality assurance efforts in clinical trials at Genmab, a pioneering biotech company dedicated to transforming the lives of patients with cancer and other serious diseases.We are seeking an experienced QA Senior Manager with a strong background in GCP and/or GCLP to join our global team. Your primary responsibility...
-
Senior Manager, QA GCP/PV
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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 Leader
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeRole 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...
-
Senior Manager, QA GCP/PV
4 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe 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 timeThe 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 timeThe 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...
-
Leading Quality Assurance Manager
1 week ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe are seeking a seasoned Quality Assurance Manager to join our dynamic team at Genmab. As a leading expert in QA, you will play a pivotal role in ensuring the highest standards of quality in our clinical development programs.Key Responsibilities:You will lead the review and approval process for clinical and regulatory SOPs within QA GCP/PV.You...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeJob DescriptionWe are seeking a highly motivated Senior Manager to join our Quality Assurance team in Copenhagen, Denmark. As a Senior Manager, you will be responsible for leading quality audits within the Good Clinical Practice (GCP) regulated areas, mentoring QA colleagues, developing audit strategies, and coordinating GCP inspection readiness...
-
Senior Manager, Quality Assurance and Compliance
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleWe 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...
-
Senior Manager, QA GCP/PV
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeOverviewGenmab 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...
-
Senior Manager, QA GCP/PV
1 month ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout 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...
-
Copenhagen, Copenhagen, Denmark Genmab Full timeGenmab is seeking a highly motivated QA Senior Manager with at least 5 years of experience in GCP and/or GCLP to join our global team. As a key member of the quality assurance department, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the highest standards of quality.The ideal candidate will have a deep...
-
Clinical Trials Quality Assurance Expert
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeThe RoleAre you passionate about transforming the lives of patients through innovative cancer treatment?We are looking for a highly motivated Senior Manager with at least 5 years of experience within GCP and/or GCLP to safeguard patients and ensure quality compliance in all aspects within GCP.As a QA Senior Manager, you will have in-depth and strong...
-
Senior Manager, QA GCP PV
2 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleGenmab 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 ResponsibilitiesPlan, conduct, and report quality audits within the GCP regulated areas.Mentor and train QA colleagues and...
-
Senior Manager, Quality Assurance Regulatory
3 weeks ago
Copenhagen, Copenhagen, Denmark Genmab Full timeAbout the RoleWe're looking for a highly motivated QA Senior Manager to join our team at Genmab, an international biotechnology company dedicated to improving the lives of patients through innovative antibody therapeutics. As a QA Senior Manager, you will play a key role in ensuring the quality and compliance of our clinical trials and regulated areas.Key...
