Teva Senior Manager Global Quality Compliance Computer Systems 

Croatia, Zagreb 

635634800

This role will have oversight, accountability, and associated responsibilities for projects and enhancements, deployments, and ongoing operations for assigned Global Quality Computer Systems as the Global Business Owner, including the following:

• Setting strategy and defining business priorities for global system deployments based on regulatory commitments and internal Teva initiatives
• Developing and implementing global, harmonization guidance and templates to enhance use of the systems and improve corporate-wide compliance
• Directing business activities, such as business process mapping, data and process mapping, requirement gathering, performance qualifications and site acceptance testing, and enhancement review in support of Global Quality computer systems
• May include directing activities/priorities for external contractor(s)

• Serve as the Global Business Owner for Global Quality computer systems as assigned
• Manage defined implementation projects/schedules/activities related to computer system projects and operational activities as the Global Business Owner, including global and site communications, business prioritization, and issue escalation; partner with the appropriate functions (Business, IT) to provide issue resolution
• Manage deployments per roadmap by leading all the business centric activities across all deployment phases of a given site rollout, tracking deployment status for all impacted sites/functions and escalating issues to management
• Ensure local deployments and ongoing operational activities for global Quality computer systems are aligned with global processes and standards
• Act as the Global Business Owner for system validation activities (review/approval of system requirements and other validation documentation, approval/execution of system testing, etc.)
• Participate in system change request/release review and prioritization meetings with counterparts in Information Technology (IT), Compliance, sites, and other internal Teva functions, and work with global teams to manage these requests towards features or usable workarounds
• Provide updates in Quality Global/regional/leadership meetings
• Serve as the backup to other Global System Business Owners as assigned

• Bachelor's in Science is required and advanced degree preferred in science/regulatory/computer science/management field
• Minimum of 5-7 years in pharmaceutical or related industry is required
• In-depth knowledge of pharmaceutical quality and quality systems, with broad experience and exposure to best practices
• Knowledge of cGxP requirements, Quality related IT applications, and computer system validation
• Demonstrated experience with managing complex projects
• Experience in project and/or program management leading cross-functional teams
• Must have international experience
• Technical knowledge and expertise with Quality Management computer systems including Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), Quality Control (QC) Systems, Quality Management Systems (QMS) and processes
• Experience with Veeva Quality Vault, SuccessFactors LMS, and/or LabWare LIMS preferred
• Skilled with Excel, Word, PowerPoint, MS Project and SharePoint
• Demonstrates resourcefulness and initiative and creates an appropriate level of urgency to meet objectives and deadlines
• Fluent in English
• Verbal and written communication excellence required

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