Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
Associate Director, Clinical Development and Operations Quality (Study Quality) Location : Barcelona, Spain
Reports To : Director, Clinical Development and Operations Quality (CDOQ)
This is what you will do : Under the direction of Director Study Quality, the Associate Director (AD) Study Quality Operations Lead is accountable as Quality Partner for Clinical Operations and Clinical Development globally and is responsible for driving a culture of data and risk driven quality oversight of the Rare Disease Business Unit portfolio across all therapeutic areas at asset/program level. The AD is responsible to actively engage with cross functional study teams to support a culture of sustainable regulatory compliance via the risk-based quality management principles within and across portfolio. The AD, study QOL will act as clinical compliance advisor/partner to the global study team. Additionally, this position will be responsible for proactively assessing process efficiencies and building remediation/optimization in partnership with business process owners.
Under the direction of Director Study Quality, the AD, study QOL will partner with business process owners to drive the excellence of business-critical processes/platforms such as TMF, CRO/vendor oversight etc. They will support quality oversight of the Asset level audit and GCP inspection program execution by successfully partnering with relevant quality and functional SMEs, to assure successful inspection outcomes and CAPA Plan execution. In consultation with cross-functional stakeholders and in close collaboration with other quality teams (R&D, Central etc.), Country Quality QOL, the study QOL will support all audits, inspection readiness, preparation and management, Quality Event management and CAPA Plan development, and execution to closure. This includes but is not limited to proactively identifying and communicating/escalating critical-to-quality risks and issues to Clinical Development and Operations Management, including GPT, RST etc., and supporting these risks and issues through action and resolution.
You will be responsible for:
In alignment with Director Clinical Development and Operations Quality, the AD, Study QOL supports development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio across all Therapeutic Area(s) (TAs).
Where applicable, represent CDOQ Quality on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategy to drive excellence in study execution and to minimize risk to regulatory submission/approval.
Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality Management.
Serve as the quality expert for global/systemic clinical quality issue investigations, which includes:
In collaboration with Clinical operational/development issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis.
Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs.
Reviews and approves Deviations and CAPAs.
As appropriate escalate issues of critical noncompliance and/or lack of urgency in remediation to CDOQ and appropriate operational Leadership.
Where applicable provide appropriate quality metrics for established Quality Management Reviews (Global Quality, R&D etc.).
Be accountable for leading inspection readiness for assigned programs/portfolio including but not limited to:
Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance.
Provide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.).
Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic Area.
Serve as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements etc.
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