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Global biotechnology company that invests in scientific innovation.
Job Description
General Summary:
This individual will have overall responsibility for lifecycle review of risks to quality through ensuring appropriate oversight, mitigation strategies and plans enabling clinical quality outcomes and real time inspection readiness.
This individual will partner closely with the Therapeutic Area leads and program leadership in the design and execution of program quality strategies and provide transparent insights into program risks and issues to will deliver proactive and sustainable clinical quality and compliance.
This individual will utilize their regulatory intelligence and technical expertise to optimize interdisciplinary understanding, synergy to integrate activities across GCP QA and functional stakeholders to optimize inspection readiness and preparedness objectives.
This individual is responsible to support the PQL/SQL in the development and oversight of internal and external inspection readiness management, as well as supporting inspections within GCP QA organization.
Key Duties and Responsibilities:
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