Quality Event Assessment and Investigation Lead (Sr. Manager)

As part of the Clinical Quality Team you will be responsible for the assessment and investigation (including root cause analysis and inspection readiness documentation) of GCP quality events a cross the Clinical Development Portfolio .

The Quality Event Investigation Lead will be accountable for managing confirmed Significant Quality Event (SQE) case

through the investigation process including root cause analysis. The Quality Event Investigation 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 Quality

Event Investigation Lead will lead the SQE team in the development of appropriate Corrective and Preventative

Actions (CAPA) and assign completion dates to action owners that ensure actions are progressed quickly to

completion.

Serious Quality Event Investigation

He or she 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 the enable an investigation with

appropriate quality outcomes including a well written case summary (meets defined quality standards) which

can be used in a regulatory inspection. Case summaries should not require more than a single round of

review by an approver.

Case documentation will be complete and accurate and filed as necessary to ensure inspection readiness. He

or she will appropriately escalate concerns regarding the progress of a case or a SQE teams resistance to the

implementation of appropriate CAPAs so that it can be addressed and resolved in a timely manner.

The Quality Event Investigation Lead will be responsible for managing all extension requests for cases, actions

and CAPA effectiveness checks so that approvers are given adequate time to approve before the case goes

overdue.

Qualifications:

BS - 10 years or equivalent · MS/MBS - 5 years or equivalent · PhD/MD - 3 years or equivalent Previous Experience: · Minimum of 10 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory. · Regulatory inspection experience · Detailed knowledge of clinical trial processes and relationships required · Knowledge of GCP requirements and applicable SOPs and regulations · Project management, resource management (staff and financial), administrative, and technical capabilities are required, as well as effective verbal and written communication skills · Strong scientific background in Life Sciences, Regulatory Affairs, or higher degree preferred.

Last Date to Apply for Job: 7/27/2021

Eligible for Employee Referral Bonus: YES

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