Social network you want to login / join with :
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 activities performed by the Clinical Affairs team, supporting the testing and registration of diagnostic tests across a diverse portfolio of indications. The scope of the trials is global, including multi-centre trials managed from several locations.
Key responsibilities :
* Ensure compliance during trial activities, such as closure of deviations and handling complaints, in collaboration with the Clinical Affairs team.
* Represent Clinical QA in project teams for clinical trials, including reviewing clinical 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 experience.
* Proven experience as a Clinical Research Associate or similar, with knowledge of relevant regulations and standards.
* Desirable: experience with In Vitro Diagnostic or Medical Device Regulations.
* Desirable: experience as an Auditor or Subject Matter Expert in regulatory inspections.
* Willingness and ability to travel internationally (Europe + USA) up to 10%.
* Ability to work independently with good judgment within defined practices and policies.
* Excellent communication and interpersonal skills, effective with multinational and multicultural teams.
If interested, please send your CV to schedule a conversation.
J-18808-Ljbffr
#J-18808-Ljbffr