QA for QC Senior Specialist (GMP QA)
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Location: Ballerup
Time Type: Full time
Posted On: Posted 2 Days Ago
Job Requisition ID: R10145
At Genmab, we’re committed to building extraordinary futures together, by developing antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.
The Role & Department
Genmab’s clinical pipeline is in an exciting growth period, and we are looking for a QA for QC Senior Specialist to join the GMP Quality Assurance (QA) in Denmark.
In this position, we are looking for an enthusiastic and experienced candidate to further strengthen the quality area at Genmab. You will be part of a small QA team setting the quality direction for Genmab’s newly established Quality Control laboratory and provide QA for QC expertise within GMP QA.
As QA for QC Senior Specialist, you will be an important part of the global GMP QA team to ensure compliance to industry standards and regulations. You will report to Team Lead QA GMP Early Development.
Key Accountabilities
- QA responsibility for the activities at Genmab’s QC laboratory.
- Promote collaborative relations with relevant internal stakeholders and CMOs.
- Provide QA Support for qualification of analytical instruments as well as analytical method qualification and validation.
- Perform SOP review and writing, handling deviations, CAPAs and change controls.
- Support Genmab’s QC laboratory in building robust, simple and preferably paperless processes.
- Handling OOS/OOT in collaboration with the GMP QA teams.
- Enable inspection readiness by ensuring documentation, procedures and processes are maintained in compliance with company and industry standards and global regulations.
- CMO oversight, e.g. participate in audits of suppliers and contract laboratories.
Skills & Experience
- You hold a MSc degree or equivalent in a relevant life science subject.
- You have +5 years’ experience from the pharmaceutical industry preferably within QA for QC.
- Experience with analytical methods for biologics/monoclonal antibodies is an advantage.
- Lead auditor experience is an advantage.
- You have excellent communication skills in English, and a collaborative mindset.
- You are result and goal orientated and committed to contributing to the overall success of Genmab.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best and take pride in enabling the best work of others on the team.
- You have experience working in a fast-growing, dynamic company (or a strong desire to).
- You work hard and are not afraid to have a little fun while you do so.
Our commitment to diversity, equity, and inclusion
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.
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