Careers

RA/QA Director

Full-time position

Introduction

Have you been working in a large organization on defining and managing a QA/RA organization and do you have the feeling it’s time for a change? Do you have the desire to work in a more agile and growing organization that will energize you to build a service-focused QA/RA organization? Do you have an in-depth knowledge, and a track record to define the RA requirements for our products? Have you implemented a QMS system and driven improvement on process and product quality initiatives? We might just have the perfect new job for you!

As our new RA/QA director you will be working on defining the RA requirements for our products. 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. In this position, you will report to the COO.

Location: Amsterdam, The Netherlands   

Apply now Meet LUMICKS

What are my tasks & responsibilities?

  • Define RA requirements in Product Development process
  • QMS system company
  • QA process & product improvements
  • Ensure that the product approvals are obtained
  • 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 all LUMICKS departments in the implementation of quality methods and regulations; educate colleagues on the sense and logic of quality assurance & regulatory affairs
  • 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
  • Advise LUMICKS strategy team on regulatory implications of strategic opportunities
  • Represent LUMICKS regarding QA/RA at external contacts ranging from government to commercial partners and suppliers

What about my skills & competencies?

  • You have an Academic degree in technology or pharma
  • Minimum of 10 years of Quality Assurance & Regulatory Affairs work experience in pharma / IVD industry
  • Proven track record in a QA/RA lead position in a high technology company active in the IVD field
  • In-depth knowledge of relevant standards and regulations, including ISO13485 / GMP / MDSAP / IVDR / CFR
  • 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 creative and solution-oriented in resolving challenges in an agile environment
  • A team player, forward thinking, energetic, enthusiastic and pro-active.
  • Excellent communication and interpersonal skills, and professional demeanor

About LUMICKS

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.

Why Join?

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.

Growth opportunities

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.

Join our newsletter

Join our newsletter

Get exclusive news on the latest publications, product developments, events and breakthrough science.

By agreeing to receive marketing communications, you subscribe to our newsletter. You can change your mind at any time by clicking the unsubscribe link in any marketing email you receive from us. By submitting the form you agree to LUMICKS' privacy policy.

Download our webinar recording:

 

Download our Cell Therapy (CAR-T, TCR, NK) applications deck