In this position, your main responsibility is to play a central role in building up and implementing the quality management system (QMS) within the company. You will be the driving force in the company's transition from ISO 9001:2015 to GMP.
My client is a biotech company with two decades of expert experience in its proprietary CLIPS technology and in providing peptides and peptide services to pharmaceutical and biotech companies as well as universities. In a continuous effort to provide the highest quality for its customers' clinical trials, the company seeks to raise its quality system from ISO 9001:2015 to GMP. Therefore, as a strategic step, my client is hiring a Quality Assurance Lead to implement and execute GMP.
As Quality Assurance Lead, you proactively identify the need for improvements with regard to quality performance and initiate and contribute to improvement projects. My client is looking for a strong communicator with excellent interpersonal skills. You are a natural leader and know how to motivate people and win them over.
Core tasks and responsibilities of the Quality Assurance Lead are:
- leading the transition of the company towards a full valid GMP environment;
- releasing of products for distribution;
- maintaining the quality management system (evaluation, advising, designing, implementing and monitoring of procedures);
- in cooperation with your team determining the quality standards and SOP's and, consequently, monitoring these;
- conducting internal audits to ensure compliance and brief the CEO on the progress of implemented solutions to improve the QMS;
- In case of customer complaints, gathering required information in preparation for the root cause analysis;
- trending of customer complaints;
- maintaining communication with the QA department of suppliers;
- hosting regulatory and customer audits.
- a Master's degree in Life Sciences or a related field;
- at least 4 years of experience in a GMP environment;
- experience as a Quality Lead in a GMP environment is a pre;
- familiar with conducting internal and external audits;
- knowledge of and practical experience with quality management systems;
- first-rate communication skills at various levels in both Dutch and English;
- a quality-oriented, pro-active, flexible, accurate, hands-on mentality, stress-resistant, pragmatic, decisive team player with proven problem-solving skills.
Excellent salary and secondary benefits