How you’ll spend your day
Serve as an initial point of contact for Veeva Global GxP business questions related to QMS and EDMS processes.
Act as a primary business liaison with the IT support (FAS) team for operational support activities.
Lead updates to system-specific SOPs, WIs, CBTs as driven by business needs.
Review and approve master data requests.
Enhancement/change reviews:
Triage and initial review of system standard releases and new feature requests and business enhancement requests for feasibility with IT.
Participate in system change request/release review and prioritization meetings (Change Advisory Boards) 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.
Support Global Business Owners during enhancement and change request reviews with the Business globally, including managing global business reviews of enhancement requests and compiling business feedback as part of enhancement planning.
Ensure ongoing operational activities for the Veeva Global GxP system are aligned with global processes and standards.
Conduct additional business training as needed post go-live to help adoption at sites.
Partner with the appropriate functions (Business, IT) to provide issue resolution.
Escalate issues to management as needed.
Participate in system periodic and user access reviews.
As needed, act as a Global Business Owner for system validation activities for operational changes (review/approval of system requirements and other validation documentation, approval/execution of system testing, etc.).
Provide updates in Quality Global/regional/leadership meetings as needed
Your experience and qualifications
Bachelors in Science is required and advanced degree preferred in science/regulatory/computer science/management field
Minimum of 7-9 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 and deployment
Demonstrated experience with managing complex activities
Must have international experience and experience working with large cross-functional teams
Technical knowledge and expertise with Quality Management computer systems including Electronic Document Management Systems (EDMS)and Quality Management Systems (QMS) and processes (such as deviations, CAPA, laboratory investigations, complaints, trends, change control, document management, notification to health authorities, notification to Management, etc.).
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
Veeva Quality system knowledge a plus
