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QA Senior Manager
4 weeks ago
Are you passionate about revolutionizing cancer treatment and dedicated to ensuring the highest quality standards in clinical development?
We are seeking a highly experienced QA Senior Manager to join our team at Genmab, a company driven by innovation and a commitment to transforming lives. In this role, you will have the opportunity to work on cutting-edge projects, collaborate with global teams, and leverage your expertise to drive excellence in our Quality Management System (QMS).
About the Role
- You will be responsible for representing QA GCP in cross-functional groups, driving process improvements, and ensuring compliance with regulatory requirements.
- As a seasoned QA professional, you will lead the SOP review process, optimize workflows, and engage with stakeholders to ensure seamless collaboration.
- With strong analytical skills and attention to detail, you will conduct thorough reviews and approvals of clinical and regulatory SOPs, identifying areas for improvement and implementing effective solutions.
Requirements and Qualifications
- You hold an MSc in Natural Science or a similar field and have at least 5 years of experience in QA GCP and GCLP.
- You possess solid project management skills, with a proven track record of coordinating QA activities, managing complex tasks, and prioritizing deadlines.
- Your expertise includes clinical CAPAs, deviation, and change control handling within GCP, with the ability to train staff members and communicate effectively.
- You are proficient in Veeva Vault QMS and have a strong understanding of ICH E6(R3) regulations.
- You excel in written and verbal communication, able to craft compelling SOPs and deliver engaging training sessions.
What We Offer
- A competitive salary of $120,000 - $160,000 per annum, depending on location and experience.
- A hybrid work arrangement, allowing for 60% on-site presence and 40% remote work.
- The opportunity to work in a fast-paced, dynamic environment with a talented team of professionals.
- Ongoing professional development and growth opportunities.
About Us
Genmab is a leader in innovative cancer treatment, leveraging cutting-edge technology and science to transform lives. Our agile working environment fosters collaboration, creativity, and a passion for excellence.
