GMP QA Manager
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 a QA GMP Manager you will conduct audits internally as well as externally at CMO’s and other collaborators. You are responsible for writing audit reports and follow-up on audits. In this function you will be highly involved as QA support of GMP development work and release of batches.
As part of the QA department, you are an active collaborator within Genmab.Key Accountabilities
The responsibilities of the GMP Manager will include, but not be limited to:
- Being an active QA representative in both the early and late stages
- Act as Delegated Qualified Person
- SOPs, batch record review, deviations, CAPAs, change requests and quality agreements
- Providing internal QA support in the organization
- Cooperating with external CMO’s
- Performing Quality Audits within GMP regulated areas both internally and externally
- Provide proficient quality input and drive updates of Genmab’s Pharmaceutical Quality System
- Balancing Genmab’s current development phase with regulatory requirement
Moreover, the employee shall participate in training and education of employees in GMP guidelines and regulations to ensure activities are conducted in compliance to GMP and other regulatory requirements.Skills & Experience
- You hold a BSc or MSc in a relevant life science subject
- You have 5 or more years relevant industry experience within GMP and have outsourcing experience
- Trained auditor is beneficial
- You have experience in training colleagues in SOP’s and GMP
- You have experience working in an EDMS system, such as Veeva Vault document management
- You have biologics and/or validation experience
- You have excellent communication skills in both English and Danish, and a collaborative mindset
- You are willing to travel globally for up to 20-25% of your work schedule
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 Uthen Khamproh (email@example.com).
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To learn more about Genmab, you can visit our website: http://www.genmab.com/