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Senior Issue Lead
Role Responsibilities

Quality Events: managing confirmed Major / Critical Quality Event (QE) cases through the investigation process including root cause analysis. The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. The Senior Issue Management Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those is evidenced in documentation as required. The Senior Issue Lead will be assigned to and manage Critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT).

Audits and Inspection Coordination: Drive GCP quality inwithstanding regulatory scrutiny, operational data and documentation. Major areas of focus will include:

Audit coordination for GCP related process and preferred CRO vendor audits.
CAPA management.




Directing inspection readiness and providing inspection support for GCP sponsor inspection activities.

Quality Event Investigation
The 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 which includes a case summary that meets defined quality standards and can be used for a regulatory inspection. The Senior Issue Lead will perform quality review and approval of select quality events that have been managed by other investigation leads. He/she will be assigned to process improvement initiatives and special projects as necessary and be expected to drive changes to the business process for case management when the need arises.
Training and Technology
This individual will also be required to mentor and train Is

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📌 Senior Issue Lead (San Juan)
🏢 Atomic Hr
📍 San Juan