Job Information
CSL Behring LLC Senior Manager, Business Systems Architect, Global Clinical Safety & Pharmacovigilance in KING OF PRUSSIA, Pennsylvania
Serve as solution architect and technical advisor on concurrent projects, including coordinating internal I&T services, facilitating vendor collaboration, and direct management of contracted technical resources. Provide technical leadership to GCSP application support team, including knowledge transfer of new implemented systems, and guidance on complex support issues. Perform as primary technical escalation contact for critical operational support issues. Accountable for the ongoing operation and maintenance of applications for the assigned IT functional areas, including the definition and monitoring of the measures to ensure system availability. Accountable for the effective and efficient provision of 2nd or 3rd level incident support, change management, and maintaining the upkeep of technical records and documentation. Proactively communicate the status of ongoing daily support and problem resolution. Ensure effective problem analysis and resolution of issues of complex scope in a timely fashion and escalates issues when needed to appropriate levels of IT or Business. May provide off hours support as it relates to the IT functional area. Directs and conducts research and analysis on new and innovative solutions, releases, enhancements and considers their applicability to CSL. Lead the identification and implementation of means to improve the qualities and efficiencies of IT processes, systems, and results. Keep abreast of current technologies, associated strategies and professional concepts as it relates to the assigned IT functional area. Contribute to CSL's overall Data strategy by providing subject matter expertise and technical facilitation to global data projects. Prepare training materials and user manuals. Design and conduct user training sessions, with emphasis on relating the configuration and technical setup to the business requirements and defined CSL enterprise application standards. Contribute to identifying enterprise standard approaches to training as applicable to the CSL framework. Effectively follow global IT procedures and policies are followed consistently as defined by our Quality Management System (cQMS). Follow the appropriate global regulatory guidelines and current Good Manufacturing Practice (cGMP). Up to 10% international travel required. May work from home.
*REQUIREMENTS: *
Bachelor's degree (or foreign equivalent) in Computer Science, Information Systems, Engineering, Mathematics, or related field plus 8 years of experience in the offered position or related position.
*Employer will accept a 3 year Bachelor of Commerce from an accredited institution in India.
SPECIAL REQUIREMENTS:
Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be "quantified" by "time". Required expertise/knowledge includes:
- Operational experience working with complex, large-scale technical environments.
- Experience directly supporting Pharmacovigilance operations.
- Experience working in a controlled regulatory or pharmaceutical environment with applied GMP knowledge.
- Experience managing IT projects within a global environment.
- Knowledge of Drug Safety and Safety Database with Special focus on E2b area.
- Knowledge of Oracle Argus.
- Experience in Axway B2Bi upgrade/implementation.
- Experience on Application Lifecycle Management tools, including HPQC and CodeBeamer.
- Experience in SQL, PL/SQL code development and maintaining source code in code management tools (GitHub).