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QP (Qualified Person)
4 months ago
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This position is part of the Regulatory Affairs & Compliance department located in Fargo, ND and will be remote with some travel. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Regulatory Affairs & Compliance team and report to the Director of Regulatory Affairs & Compliance responsible for planning, developing, and executing domestic and international regulatory compliance strategies related to statutory expectations and guidance documentation.
In this role, you will have the opportunity to:
- Certify each batch of medicinal product has been manufactured in accordance with EU CGMP for Sterile Products requirements and with the provisions of the marketing authorization.
- Obtain authorization required for importation and exportation of products where relevant.
- For investigational medicinal products coming from third countries, the QP must certify that each batch has been manufactured and checked in accordance with standards of cGMP at least equivalent to those of the European Union, in accordance with the product specification file.
- Routinely monitor the company's operations to ensure compliance with site licenses and current Good Manufacturing Practice bringing any critical and major deficiencies to the attention of Management.
- Ensure any changes requiring variation to the manufacturing authorizations (MIA and IMP licenses) have been notified and authorized by the relevant authority.
The essential requirements of the job include:
- QP Qualification with at least 8 years of Regulatory experience in an EU licensed facility in a relevant functional area.
- Maintain QP Registration and a knowledge of the Role and Responsibilities of the QP.
- High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management.
- Excellent oral and written communication skills.
- Up to 25% travel.
It would be a plus if you also possess previous experience in:
- Biologics and ATMP manufacturing experience highly desirable
- Aseptic / Sterile Drug Product manufacturing experience highly desirable
- Advanced degrees (eg, MS, PhD, JD, MD) are preferred.
At Aldevron we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide.
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
