Ncardia is an established, globally operating, stem cell-based drug discovery & cell therapy company. At Ncardia, we believe that stem technology will help bring better therapies to patients faster. The goal of the company is to be the supportive and trusted partner for scientists operating within the human induced pluripotent stem cell (hiPSC) drug discovery and cell therapy fields, and in particular, in the cardiovascular and neurology space.
Ncardia develops, produces and commercializes hiPSC based solutions. Our offerings extend from concept development to pre-clinical studies, including custom manufacturing of a range of cell types, as well as discovery services such as disease modelling, screening, and safety assays. Manufacturing process development expertise supports the development of cell therapy products
We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution. Within our global QA team there is a position immediately available for a (Senior) Quality Systems Officer, who will report to the Chief Quality Officer
For more information about the company, please visit our website www.ncardia.com.
The Quality Systems Officer will hold responsibility for building and optimizing our global Quality Management System, on a project basis. Ncardia has an ISO9001 based Quality management system for its research cell products that needs to be optimized and extended to the rest of the organization to support Ncardias business goals in drug discovery and cell therapy.
As Quality Systems officer you will join Ncardias QA team, you will lead key projects focused on building and optimizing the existing QMS, and support QA operational activities on a case by case basis.
Tasks and Responsibilities include (but are not limited to):
- Project lead QMS building and optimization
- Produces high-quality documentation that meets all applicable standards, both according to industry best-practices and according to internal work instructions, and is fit for the intended business
- Performs evaluations, GAP analyses and risk assessments
- Advises on process improvements
- Supports execution of site/team continuous improvement goals and projects
- Providing training on implemented processes and guidelines
- Support of general QA Operational activities on a case by case basis
- BSc/MSc or equivalent working and thinking level in Life Sciences
- 5 years relevant work experience (e.g CRO or CDMO)
- Vast experience with implementing Quality Systems on a project basis
- Experience with Lean and Kaizen
- Experience with implementing eQMS/eDMS and Vendor Management as well as preparing for new facilities is a plus.
- Knowledge of GxP, GAMP and/or APIs are a plus
- Experience with ISO9001, GLP quality systems and/or ITIL is a plus
- At least 1 year QA experience in a biopharmaceutical product or life-tech industry environment
- Knowledge of quality regulations and industry standards (theory and practice)
- Experience with ISO9001 regulations (ISO9001:2015 is a plus)
- Highly motivated, proactive, accurate, and committed team worker
- We expect commitment and flexibility as well as reliability and open mindedness.
- Demonstrated experience prioritizing conflicting demands in a fast-paced environment
- Ability to deliver high quality documentation, paying attention to detail
- Excellent verbal, written, and presentation skills with the ability to communicate clearly in English
- Experience in working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
- Good communication skills and team-player
- Good knowledge of Microsoft Office
Leiden (NL) / Gosselies (BE) / home office (to be discussed, as long as weekly travel to at least one of the locations is an option, as well as regular travel to the other location)
We offer a challenging position in a dynamic biotech company with room for personal growth and development. Depending on your education and experience, we provide an appropriate salary.
For questions or further information about this vacancy, please contact Wendie Hamelink (Wendie.firstname.lastname@example.org).
Send your motivation letter with curriculum vitae by September 18th to: email@example.com