TQ&C GDS Regional Director Europe provides TQ&C strategic leadership and stakeholder leadership management in the region. He/she applies risk-based Quality strategies to provide the most agile, innovative, and timely solutions that safeguard Product Quality, Patient Safety and Data Integrity. Working with the TQ Pillars to lead the execution of validation/qualification of applications, infrastructure, and Digital Health solutions to ensure they operate according to business and regulatory requirements, ensures compliance of systems across the region in accordance with J&J Software Development Life Cycle and Computer System Validation Framework, assures compliance within the enterprise with applicable global regulations, advises on quality matters, and assists with closing compliance gaps related to audits and inspections.
The TQ&C GDS Regional Director Europe, manages and directs regional TQ Managers/Specialists and Contractors performing activities within the region to ensure an integrated and comprehensive Quality and Compliance approach for computerized systems are implemented and maintained.
Required Knowledge, Skills and Abilities: