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Quality Assurance Manager
1 month ago
We are seeking an exceptional Quality Assurance Manager to join our team at Genmab. As a senior manager in QA GCP/PV, you will be responsible for ensuring clinical compliance in all aspects within GCP.
Key Responsibilities- Represent QA GCP in the Clinical Development Process Expert Group (PEG) and Regulatory Registration PEG, coordinating and planning SOP development and revisions.
- Take the lead on the SOP QA review process, optimizing and aligning the process of QA review and approval of clinical and regulatory SOPs within QA GCP/PV.
- E nsure transparency and overview of all clinical and regulatory SOPs reviewed and approved by QA.
- Conduct QA review and approval of clinical and regulatory SOPs, engaging QA colleagues to ensure timely completion.
- Lead the revision of GCP/PV QA SOPs, incorporating input from QA colleagues and ensuring applicable information is reflected.
- Write GCP/PV QA relevant SOPs, meeting deadlines and timelines.
- Coordinate internal GCP/GCLP training or deviation/CAPA/Change Control processing.
- Host and manage the GCP and PV mailboxes, ensuring structure and organization.
- Deliver GCP advisory expertise within the company and to external vendors.
- Identify opportunities to advance our work through AI or similar technologies.
- Coordinate and participate in GCP/PV inspection readiness activities.
- MSc in Natural Science or similar, with at least 5 years of experience in QA GCP and GCLP.
- Solid project management experience and coordination skills for QA activities.
- Solid experience in clinical CAPAs, deviation, change control handling within GCP, with training capabilities.
- Practical proficiency in Veeva Vault QMS.
- Strong written and verbal communication skills for SOP writing and GCP training.
- Knowledge of IT requirements for data processing is an advantage.
- You are passionate about our purpose and genuinely care about transforming patient lives through innovative cancer treatment.
- You bring rigor and excellence to your work, believing in our science-driven approach.
- You are a collaborative team player with diverse backgrounds.
- You strive to do your best and take pride in enabling top-notch team performance.
- You are not afraid to innovate and grapple with unknown challenges.
- You have experience working in fast-growing companies or desire to.
- You work hard and enjoy having fun while doing so.
The estimated salary for this role is $120,000 - $180,000 per year, depending on location and experience. This is a hybrid role with 60% on-site presence and two days of remote work per week.
