I'm working with a Barcelona based leading centre for molecular diagnostics, focusing on companion diagnostics and personalized healthcare in oncology. They design and develop diagnostic products, utilising RNA and DNA technologies.
In this role as a Senior Quality Assurance specialist, you will take on responsibility for quality and compliance oversight of the activities performed by the Clinical Affairs team, in support of the testing and registration of diagnostic tests covering a diverse portfolio of indications. The scope of the trials is global and includes multi-centre trials managed out of several different locations.
Key responsibilities :
* Work with members of the Clinical Affairs team to ensure compliance during trial activities – e.g. closure of deviations, complaints etc.
* Represent Clinical QA as a member of project teams for planned and ongoing clinical trials, including Quality review of clinical relevant documentation
* Support qualification and perform independent QA audits of clinical study sites
* Participate in the internal audit program
* Review Clinical Affairs SOPs
Position Requirements
* Degree qualification in a relevant subject, or equivalent employment experience
* Proven working experience as a Clinical Research Associate or similar with knowledge of relevant regulations, standards, guidelines and best practice
* Desirable : working knowledge of In Vitro Diagnostic or Medical Device Regulations
* Desirable : experience as an Auditor and / or Subject Matter Expert in regulatory inspections
* Willingness and availability to travel internationally (Europe + USA) up to 10%
* Ability to work independently while exercising good judgement and decision making within defined practices and policies
* Excellent communication and interpersonal skills with the ability to work effectively with multinational / cultural teams and individuals
If you are interested please send over your CV and we can schedule a conversation.
Thank you
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