Black Swans Exist | Recruiting talents for life science companies

You Want

To take on a transformative role within a new division where you can make a significant impact from day one. As the QA specialist, you want to use your authority to approve documents, conduct reviews, and facilitate releases. More importantly, you will have the opportunity to shape the development/R&D projects and establish seamless collaboration with the CMO. You want to assume full responsibility and become the go-to expert in this domain. Your guidance and expertise will chart the course for future development, allowing you to make a lasting impact and drive innovation within the organization.

You Will

Play a crucial role as a QA Specialist in product development. Your primary responsibility will be to develop a dedicated Quality Management System (QMS) specifically tailored for development products, integrating it with the existing QMS for commercial products. This system will facilitate collaboration with internal development departments, external CMOs, and vaccine manufacturing companies for Phase I, II, and III clinical trials. Your expertise in understanding regulatory guidelines and requirements for sterile, non-sterile, human, and veterinary products will be essential in ensuring the quality of our development products. You will actively participate in development projects, drafting important documents like SOPs, and conducting risk assessments. Compliance with regulatory requirements will be a key focus, and you will manage deviations, CAPAs, change cases, and review batch documentation. Additionally, you will maintain the department’s quality system, process SOPs, and collaborate with cross-functional teams to identify and drive improvements in our overall Quality Management System (QMS) and related processes.

You’ll Join

a passionate quality department that works together to set a high standard for collaboration across the organization. You will join a collaborative and supportive environment that allows you to grow. The team is dedicated to keeping the world safe and is passionate about driving change. You will be part of a world-leading adjuvant specialist organization that operates across 37 countries.

You Have

• A Master’s degree in natural sciences.
• A minimum of five years of GMP experience from the pharmaceutical industry, preferably within sterile production
• Experience with CMO collaboration
• Experience with development products in different phases, preferably phase 1 and 2
• A positive attitude and good communication and collaboration skills.
• A sense of responsibility and are initiative, flexible and work in a systematic and structured way.
• The ability to work independently by planning your daily tasks, while being part of the department and sharing knowledge with your colleagues.
• Joy in working in a team and contributing to the department with a sense of humor and a good mood.
• Good English skills, both written and spoken