A career at our company is an ongoing journey of discovery: our around 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: Are you curious to build something new in the field of quality and want to work at a place where others go for holidays?
We are looking for an experienced Quality professional to join a new role as Quality Assurance Director – Bioprocess Center for a new development site. We are offering a unique experience to design and implement the Biopharmaceutical Quality System at the new Bioprocess Center (BPC) and to build a strong quality assurance organization. At the BPC we will develop New Biological Entities so that the development, production, quality control, storage, stability and clinical trial supply of the pharmaceutical products are carried out in compliance with the international good development and clinical-phase and technology appropriate GMP quality standards.
Main responsibilities are:
- Leadership of the local QA organization encompassing all development products managed at the site.
- Establish and maintain the local quality system and governance and provides quality oversight for the site and functions within scope
- Ensure the maintenance of appropriate Health Authority authorizations
- Ensure the continuous improvement of the processes in the quality field locally and globally within the global network of development sites
- Ensures the appropriate risk-based methodologies are adopted and implemented at the site.
Who you are?
- At least 10 years’ work experience in quality assurance, quality control, manufacture and/or development of biopharmaceutical products preferably in Drug Substance development.
- Min. of 5 years’ work experience in new product development.
- Demonstrated expertise in GMP QA systems, in drug legislation and regulations
- Strong ability to work in international, multi-cultural teams with string focus on project management
- English fluent
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com