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(FHF-639) | Director, Clinical Development Quality Operations
hace 1 semana
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.
Director, Clinical Development Quality Operations
Reports To: Sr Director, Clinical Development Quality Operations
Location: Barcelona, EST
This is what you will do:
Act as the R&D Clinical Quality Key Point of Contact for major processes/platforms such as TMF, CTMS, Vendor quality oversight, and medical devices.
Drive excellence in major processes/platforms within the Clinical Development Quality Operations team, collaborating with R&D owners.
Provide Quality Operations guidance to other Quality Operations Leads and Clinical Development teams.
Be accountable for the development and implementation of a global strategy to improve quality for assigned registrational and non-registrational programs.
Identify, evaluate, and drive remediation of risks and quality issues within Clinical Development programs.
Ensure inspection readiness for GCP inspections in the assigned portfolio.
Mentor Quality Operations Leads to assure program alignment and team engagement.
You will be responsible for:
Serving as the R&D clinical quality lead for assigned programs, product portfolio, and/or therapeutic area.
Developing and managing project plans to ensure timely and on-budget delivery.
Developing an overarching strategy for proactive and sustainable clinical quality and compliance.
Ensuring compliance with GXP (e.g., GLP, GCP, and GVP) requirements.
Advising on compliance matters and supporting program teams in deviation management.
Managing quality and compliance issues within the portfolio and/or therapeutic area.
Supporting root cause analysis of compliance issues and providing metrics for tracking and reporting.
Leading risk-based quality management for clinical protocols.
Participating in Due Diligence and integration activities as appropriate.
Ensuring timely completion of corrective and preventive actions (CAPAs).
Escalating critical noncompliance issues to senior management.
Advising on the development of audit strategies for clinical programs and vendor audits.
Developing quality governance for defined clinical vendors and monitoring vendor quality performance metrics.
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