QA GMP Manager
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 quality area of Genmab is growing and looking for a new colleague. As QA GMP 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 with Genmabs 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 highly involved as QA support of GMP development work and release of batches.
The QA at Genmab currently employs 10 people located in Denmark and US and reports to Head of QA.Key accountabilities
The responsibilities of the QA GMP Manager will include, but not be limited to:
- QA support related to batch release from both early and late stage projects, in close cooperation with CMO´s
- SOPs, batch record review, deviations, CAPAs, change control and quality agreements
- Act as Delegated Qualified Person
- Secure inspection readiness and perform Quality Audits within GMP regulated areas both internally and externally
- 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
- Balancing Genmab’s current development phase with regulatory requirement
Moreover, the employee is expected to support continuous 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 MSc degree or equivalent in a relevant life science subject
- You have +5 years relevant experience from a related area within GMP, preferably within biologics.
- Outsourcing experience
- QP or delegated QP experience
- Experience working in an EDMS system, such as Veeva Vault document management is an advantage
- You have excellent communication skills in both English and Danish, 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.
If you would like additional information about this position before applying using the link, please contact Recruiter Jannie Jensen (email@example.com).
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To learn more about Genmab, you can visit our website: http://www.genmab.com/