Associate Director, QA GCP/PV

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

The Role

We are looking for a passionate Senior GCP/PV QA Manager, who will support the quality in Genmab’s promising product portfolio and promote GCP and safety compliance and continuous process improvement. As part of the QA GCP/PV team, you are an active collaborator within Genmab.   

Depending on your experience, you may conduct GCP/PV audits externally at our clinical investigator sites, CRO incl safety CRO audits, as well as process based internal audits or supervise audits conducted by contract auditors. You will be responsible for the entire process from planning, conducting, reporting audits and review audit responses through to audit closure. 

You will provide support to the Genmab clinical and safety teams regarding GCP/PV interpretation and regulatory requirements covering the entire lifecycle of clinical trials, and you will play an important role in the maintenance of Genmab’s QMS, including review of SOPs, working with Deviations, CAPAs and other compliance related tasks. Depending on your experience, you may also become involved in Inspection support.

The team includes 7 passionate and experienced colleagues with a good quality mindset, a pragmatic and result oriented QA approach, and where the team mindset and team cooperation is highly appreciated and important.

As Senior GCP/PV QA Manager you will work in a multidisciplinary international QA team assessing and assuring compliance to regulations and industry standards.



You will report to Director, Team Lead, QA GCP/PV in Copenhagen. The position can be filled in Copenhagen or Utrecht.

Responsibilities

The responsibilities of the Senior GCP/PV QA Manager will include, but not be limited to:

• Be an active QA GCP/PV representative in both the early and late-phase clinical development, including oversight of global GCP (including safety) compliance

• As one of your main tasks, actively participate in the development and maintenance of the existing Quality Management System (QMS) and associated GCP/PV SOPs

• Be our “Go-To” person in regard to handling quality events (eg Deviations, CAPAs) and pulling of overview Reports from the VeeVa Quality System

• Depending on your experience and interests, plan, perform, and follow-up on Quality Audits within GCP (including safety) and associated regulated areas both internally and externally and perform vendor evaluations

• Provide internal QA support in the organization

• Participate in GCP/PV inspections performed by national/regulatory authorities

• Participate in knowledge sharing by gaining and maintaining expert knowledge about new GCP/PV guidelines, clinical trials regulations and practices, including informing relevant parts of the organization

• Participate in training and education of employees in GCP and safety requirements, and other relevant guidelines and regulations

Requirements

• You hold a Bachelor and/or Masters degree in Pharmacy/health science or any related scientific degree, alternatively you are a Nurse by training or have similar health related experience

• You have 5-6 years relevant industry experience within drug safety/Pharmacovigilance and preferably you also have experience within GCP and/or areas working in a Clinical or Quality department 

• Experience in oncology/hematology first in human trials and/or late phase is preferred

• You have experience working in an EDMS system, such as Veeva Vault document management system, including deviation and CAPA handling

• Experience in SOP and GCP/PV training and Regulatory inspections is also beneficial
  
   

Moreover, you meet the following:

• You have excellent communication skills, verbally and written, and a collaborative mind-set

• As a person you enjoy a fast-paced and a changing environment, hold a good sense of humor and enjoy team-work

• You are result and goal orientated and committed to contributing to the overall success of Genmab

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

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.

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

Scam alert

Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation.  This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.