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 RoleThe quality area of Genmab is growing and looking for a new colleague. As QA GMP Senior Manager you will work in a multidisciplinary international QA team to ensure compliance to industry standards and regulations. You will be responsible for ensuring that activities are compliant withGenmab’s Pharmaceutical Quality System. You will be responsible for operational QA activities on the assigned projects providing QA support in and outside of the organization. In this function you will be an important part of a development team and supporting a broad range of QA tasks including QP release of batches.
You have a good knowledge of GMP guidelines and regulations relevant for Genmab’s products, an interest in supporting project activities and compliance with GMP and other regulatory requirements.
The QA GMP team at Genmab currently employs 10 people located in Denmark and we can offer good development opportunities. Our new colleague will report to Head of QA GMP. The QA Department has a total of 23 employeessupporting GxP activities and located in, Denmark, the US and Japan.
ResponsibilitiesThe responsibilities of the QA GMP Manager will include, but not be limited to:
- QA support related to batch manufacturing in development projects, inclose cooperation with CMOs SOPs, batch record review, deviations, CAPAs, change control andquality agreements
- Act as Delegated QP
- Secure inspection readiness and ensure that documentation, procedures and processes supporting development programs are maintained in compliance with company and industry standards and global regulations
- Provide proficient quality input and drive updates of Genmab’s Pharmaceutical Quality System
An exciting job opportunity with many different responsibilities supporting development projects within QA. Genmab has an exciting development portfolio on the forefront of cancer treatment.
- You hold a MSc degree or equivalent in a relevant life science subject
- You have 5-10 years experience from the pharmaceutical industry within quality assurance preferably within biologics and/or sterile products.
- Experience within development products for clinical trials in late stage is an advantage
- Outsourcing experience
- Experience working in an EDMS system
- You have excellent communication skills in English, and a collaborative mindset
- As a person you enjoy a fast paced and changing environment
- You are result and goal orientated and committed to contributing to the overall success of Genmab.
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.
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 to offer a temporary agreement for one year, followed by a contract for indefinite time regardless of seniority.