As our organization develops and evolves, new roles constantly emerge. A very exciting one has just been created: Quality Director. We are looking for someone who is able to shape our Quality department as our new Quality Director. For this role we expect you to have about 10 years of quality experience in a similar environment as ours. This could be biotech, pharma or related. In this new position for our company, you will be responsible for shaping, defining and embedding quality within our organization. To flourish in our organization you need to have the desire to work in a growing and dynamic environment. You need to get energized from building a quality culture and structure and all the ups and downs that come with a process like this. It will be your job to align various stakeholders on how quality is organized in our company and you will need to influence people across different teams to adopt a quality mindset in their ways of working. For this role we expect you to come in with a backpack filled with knowledge and a sharp eye for detail to be able to show us how it’s done.
Ensure that the product approvals are obtained in a timely fashion
Set up and maintain an effective Quality Management System that is prepared for IVD/MD regulations in the future
Set up and maintain a document control system
Lead the implementation of quality methods and regulations; educate colleagues on the sense and logic of quality assurance.
Set up and manage internal and external audits to monitor the compliance with the objectives and rules of applicable quality and regulatory requirements
Explore and advise the R&D teams (CA and DSM) on applicable standards and regulations for our products
What about my skills & competencies?
You have an Academic degree in technology or pharma
Minimum of 10 years of “Quality Assurance & Management” work experience in pharma / IVD industry
Proven track record in leading change / transformation in preferably building a quality organization from scratch
Proven track record in a Quality lead position in a high technology company active in Medical Device field
In-depth knowledge of relevant standards and regulations, including ISO13485 / IEC62304, GMP / 21 CFR11 and preferably MDSAP / IVDR / 21CFR820
Experience with and understanding of technology development processes and challenges
Preferred: experience in new markets / new product development or scale-up environment
Excellent English (written and verbal) communication skills.
Structured, yet people oriented and with an natural ability to resolve challenges in an agile environment
A team player, forward thinking, enthusiastic, self-starting and leading through influencing
Excellent communication and interpersonal skills
LUMICKS has come to market as the supplier of instruments for dynamic single-molecule and cell avidity research – a rapidly evolving niche in the fundamental biology research field. Our high-performance instruments allow for the investigation into the fundamental cause of disease and potential for drug optimization. With our tools researchers can visualize and quantify the interactions between proteins and DNA in real-time, and perform high-throughput screening of molecular and cell-cell interactions using sound waves.
We offer the chance to be part of an important mission: To improve human health by unlocking dynamic single-molecule and cell avidity analysis. With an ever-increasing adoption of our technologies by leading institutes and biotech’s from all over the world, including UC Berkeley, Max-Planck, Rockefeller University and Takeda Pharmaceuticals, LUMICKS is now expanding its team.
Autonomy, ownership & responsibility
Be the leader of your own projects, and own them like no other. Whether you’re developing software or business, you are responsible for your work and the direction it goes.
With new positions opening up weekly and the company still growing exponentially, there are lots of opportunities to broaden your skill set.
Flat organization & open culture
At LUMICKS engagement is key. We try to align everyone on our dreams and strategies to unlock single-molecule and single-cell research.
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