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Client :
Cpl Life Sciences
Location : Barcelona
Job Category : Other
EU work permit required :
Job Reference :
836099995022131232460
Job Views : Posted :
31.03.2025
Expiry Date : 15.05.2025
Job Description :
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 be responsible for quality and compliance oversight of the Clinical Affairs team, supporting the testing and registration of diagnostic tests across a diverse portfolio of indications. The trials are global, multi-centre, and managed from various locations.
Key responsibilities :
* Ensure compliance during trial activities in collaboration with the Clinical Affairs team, including closure of deviations and handling complaints.
* Represent Clinical QA in project teams for clinical trials, including reviewing 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 in a relevant subject or equivalent experience.
* Experience as a Clinical Research Associate or similar, with knowledge of regulations, standards, and guidelines.
* Desirable: knowledge of In Vitro Diagnostic or Medical Device Regulations.
* Desirable: experience as an Auditor or Subject Matter Expert in regulatory inspections.
* Willingness to travel internationally (Europe + USA) up to 10%.
* Ability to work independently with good judgment and decision-making within policies.
* Excellent communication skills and ability to work effectively with multicultural teams.
If interested, please send your CV to schedule a conversation.
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