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Quality Lead Global CSV

Lonza · Colmar, Grand Est, FR

Quality Lead Global CSV (Computer System Validation) Location: Colmar - Remote The Quality Lead Global CSV plays a key role within the Quality Assurance orga...

Job description

Quality Lead Global CSV (Computer System Validation) Location: Colmar - Remote: The Quality Lead Global CSV plays a key role within the Quality Assurance organization, in close alignment with the IT /OT organization to ensure that the requirements for the qualification of computer infrastructure and validation of IT systems are clearly defined in policies, corporate quality standards, validation master plans, and standard operating procedures. The role is responsible to define qualification & validation strategies for IT/OT Infrastructure and systems, and services ensuring computerized systems comply with internal and external regulations and best practices in Pharma/Life Sciences GMP environment. Additionally, the role offers QA support to IT/OT CAPEX projects and engages with internal & external suppliers of infrastructure, applications & services to ensure compliance and high quality of service delivery. The Quality Lead Global CSV will supervise a team of CSV specialists and lead the development, implementation, and maintenance of global CSV Governance. The role is responsible for developing policies and common approach to compliance of IT/OT infrastructure and systems with 21...