Senior Issue Lead (San Miguel de Tucumán)

OverviewParexel is looking for multiple Senior Issue Leads to join our team. The candidates can be based anywhere in Argentina, Mexico or Brazil Responsibilities
- Managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis.
- Ensuring investigations are conducted thoroughly, within required timelines and to compliance requirements, ensuring adequacy of root cause analysis and appropriate communication regarding the case.
- Directing the QE team in proposing appropriate Corrective and Preventative Actions and ensuring completion is evidenced in documentation as required.
- Assigning to and managing Critical and other complex cases, especially those requiring presentation to senior leaders as part of the Quality Review Team (QRT).
- Coordinating audits for GCP related processes and preferred CRO vendor audits.
- Managing CAPA.
- Directing inspection readiness and providing inspection support for GCP sponsor inspection activities.
- Performing quality review and approval of select quality events managed by other investigation leads.
- Being assigned to process improvement initiatives and special projects as necessary.

Quality Event InvestigationThe Senior Issue Lead will ensure that each confirmed case is investigated appropriately, including ensuring investigation timelines are met and that appropriate pre-work is done on the case to enable a meaningful investigation with appropriate quality outcomes. The case summary will meet defined quality standards and can be used for regulatory inspection. Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qkkln