Principal Specialist, Computer Systems Job in Berkeley, California US
Principal Specialist, Computer Systems
The Principal Specialist will be the QA and Compliance Subject Matter Expert (SME) for the entire life cycle of Computerized systems (CS) and will provide compliance oversight on new system implementations as well as maintenance of existing systems. -Serves as SME for quality and compliance oversight on new system implementation as well as operation. 1) Determines and establishes validation/compliance requirements for a wide range of processes, systems and equipment, consistent with Corporate Directives and regulatory expectations. 2) Reviews, approves system and process documentation and ensures compliance and maintains/ updates all necessary master Plans. 3) Develops and maintains/ updates Life Cycle SOPs to ensure consistent application of the requirements and strategies. Ensures that all personnel (Bayer or contractors) utilized to perform activities have the qualification and required learnings. 4) Completes the projects in a timely manner and with high quality and accuracy. 5) Apply a Risk Based approach to systems and processes. Influences standard and simple solutions. -The ability to identify issues of significance, communicate complex issues to site leadership, provide multiple alternatives to the solution of complex problems and the ability to provide guidance in their implementation. -Advises CS group with regards to regulatory environment, changes, standards and processes. -Monitors and improves quality programs designed to oversee system compliance, in partnership with other quality leaders. -Oversees periodic assessments of systems and partners with system owners and business process owners to define and follow expectations. -Provides effective leadership in training and developing internal customers/stakeholders. Leads and motivates members of the functional areas. Supports workforce diversity, quality and safety. -Networks internally and externally to proactively remove process inefficiencies and streamlines efforts. -Represents Quality unit as SME during inspections