Associate Director, QA GCP
Job SummaryAbout Us
Genmab is an international biotechnology company specializing in the invention and development of differentiated human antibody therapeutics for the treatment of cancer and other important human diseases.The Role
You will work in a multidisciplinary international QA team to ensure compliance to industry standards and regulations. As Associate Director, QA GCP, you will conduct audits internally as well as externally at our CRO’s and collaborators. You are responsible for writing audit reports and review audit responses to audit closure. In addition, you will provide support to the clinical teams regarding GCP and regulatory requirements within the area of clinical trials conduct and be the acting chair in SOP committees.
The QA area at Genmab currently employs 13 people located in Denmark and reports to Head of QA.Key Accountabilities
The responsibilities of the Associate Director, QA GCP will include, but not be limited to:
- Plan, perform and follow-up on Quality Audits within GCP regulated areas both internally and externally and perform vendor evaluations
- Represent QA in clinical project groups or clinical sub groups and participate in cooperation with partners and contractors as appropriate
- In addition to this, the employee shall provide internal QA support in the organization and prepare/coordinate
- Participate in GCP inspections performed by national authorities
- Participate in the development and maintenance of the existing Quality Management System (QMS) and chair the SOP committee in the GCP area
- Participate in knowledge sharing by gaining and maintaining expert knowledge about new GxP guidelines, clinical trials laws, legislations and practices, including informing relevant parts of the organization
- Participate in training and education of employees in the GCP and other relevant guidelines and regulations, and ensure oversight of the company’s clinical trials is conducted in compliance with clinical protocols, GCPs and other regulatory requirements
- You hold an MSc degree or equivalent in a relevant life science subject
- You have 5-10 years relevant industry experience in the GCP area
- It is expected that you are a trained auditor
- Experience in SOP training and working in an EDMS system
- You have excellent communication skills in English and a collaborative mind-set
- Experience with early phase development phases desired. Experience with other aspects of clinical drug development such as First in Human trials, late phase development, drug safety and oncology would be beneficial
Genmab employees work with determination and with respect for each other, consistent with our core values, to achieve our common goals. We give individuals and teams the autonomy to drive development of innovative products and solutions, knowing that integrity is a core value throughout our company. 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 culture, all aiming to make a difference for cancer patients.
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. We believe that fostering workplace diversity across social, educational, cultural, national, age and gender lines is a prerequisite for the continued success of the company. We are committed to diversity at all levels of the company and strive to recruit employees with the right skills and competences, regardless of gender, age, ethnicity, etc.
If you would like additional information about this position before applying using the link, please contact Jannie Jensen (email@example.com).
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To learn more about Genmab, you can visit our website: http://www.genmab.com/