Senior Manager, Clinical Development and Operations

hace 4 semanas

Barcelona, España Alexion Pharmaceuticals,Inc. A tiempo completo

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.

**Senior Manager, Clinical Development and** Operations Quality**

**(Country Quality)**

**_Location: Barcelona_**

**Reports to**:Associate Director, **Clinical Development and Operations Quality (CDOQ)**

**This is what you will do**:
Under the direction of Associate Director, Quality Lead for Clinical Development Country Operations, the Manager Country QOL is accountable as COM quality support and is responsible for supporting a culture of data and risk driven quality oversight of the clinical trials. The CQOL is responsible for providing quality-focused guidance for execution of Rare Disease Business Unit at the country and site level.

The manager may be asked to actively engage with Country Operations Team to support a culture of sustainable regulatory compliance at country and site level via the risk-based quality management principles within and across portfolio. The Manager, QOL will be responsible for proactively assessing process efficiencies and supporting remediation/optimization in partnership with business process owners and COM organization as applicable.

The manager, Country level QOL will act as GxP advisor/clinical compliance partner to the COM team. This role will work closely with COM Team to proactively identify** **country level Key Quality Indicators (KQIs) and develops mechanisms of KQI oversight and trending.

In consultation with and under the guidance of manager supports country and site level 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, communicating and escalating site and country level risks and issues to management. This role will collaborate closely with Other CQOLs and risk/issue owners to assure systemic and systematic risks and issues are communicated in a timely manner to be managed through action and resolution.

**You will be responsible for**:

- The CQOL is responsible to support the development, implementation and continuous review of local procedural documents, and maintains current knowledge and understanding of local regulations and industry practices in relation to clinical trials
- In asupport with AD, CQOL provides advice to Local Study Teams on procedural framework including global clinical processes, procedural documents, applicable Quality & Compliance manual documents, and on international guidelines such as ICH-GCP, industry standards and local regulations.
- Supports local management in the planning and conduct of local quality control activities including but not limited to performing accompanied site visits. Performs any required QC visits / QC activities with local staff and maintains the annual quality plan updated.
- In support with AD, CQOL supports proactively identify Country 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
- In support with AD, CQOL, 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.).
- In support with AD, CQOL engage in inspection readiness for assigned programs/portfolio including but not limited to:

- Support and drive risk-based quality management (RBQM) activities for the planning and execution of clinical protocols, assuring an ongoing cycle for Plan - Do - Check - Act.
- In collaboration and coordination with other CQOLs and line manager support development of appropriate vendor quality oversight plans and processes
- In support with AD, CQOL provide guidance to team members in review of Clinical Trial Document Templates, study/country related documents, plans, SOPs, Policies, etc., as needed.
- Participate in country level meetin

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