Our client is a clinical-stage R&D company that is developing an innovative treatment for Solid Tumour oncology.

We are looking for an experienced medical device Quality Assurance professional to join the team. The main task of the role will be the implementation of QMS system in the company and quality training.

The role reports to the Head of RA and QA.

PLEASE NOTE the role is remote but requires travel to Italy every month for a few days.

Key responsibilities:

• Creation & Management Quality Management System (QMS) and all related documentation

• Ensure the execution of staff training of applicable quality requirements.

• Ensure that deviations, CAPA, change controls, quality plans, and complaints are addressed and recorded according to the applicable requirements and SOPs.

• Support manufacturing, product development, clinical and regulatory functions from a QA perspective.

• Represent the company in regulatory, quality and scientific meetings.

• Developing long-term relationships with suppliers and other key stakeholders.

To be considered for the role, you must closely match the following profile:

• A degree in a medical or scientific discipline (Pharmacy, Biologics, Chemistry, Biotechnology are preferred)

• Proven experience in quality management for medical devices, specifically ISO 13485 and MDR is a must

• Experience in releasing pharmaceutical and/or medical device batches of products in US and/or in the EU of clinical investigational and/or marketed products

• Project management experience

• Great communication skills

• Attention to detail and self-taught attitude

• Management of external partners and cross-functional teams

• High level of technical and personal capabilities; a problem-solver

• Excellent English language is a must.

• Ability to travel regularly to Italy.