21 CFR part 11 Project Manager / Program Manager

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          "text": "<p>PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience<br /><br /><br />Location: Carlsbad, CA<br /><br />Deliverables:<br /><br />• Oversee all aspects of project scope, schedule, resource, risks and overall management to ensure and drive successful delivery.<br />• Ensure the software development and project management deliverables and milestones in project plans are achieved within cost, schedule, scope, and quality.<br />• Assure that the project teams are managing the system development process including systems analysis, technical design, coding, testing, turnover to production, user acceptance criteria.<br />• Conduct proper and timely communications, change management, and training per project stakeholders and needs.<br />• Provide overall capital and operating expense project budget responsibility for multiple projects.<br />• Manage critical supplier and internal customer relationships.<br />• Maintain extensive knowledge and expertise in project management disciplines, as well as multiple business processes and/or technical areas.<br />• Experience supporting different cross-functional applications projects<br />• Any experience in CRM, ERP, Validation applications, Financial area, etc. is desirable.<br />• Leverage industry best practices to plan, manage, monitor and report on all projects<br /><br />Skills and Credentials:<br /><br />• Bachelor&apos;s degree in computer science, computer engineering, electrical engineering, systems analysis or a related field of study, or equivalent experience, and/or Master’s degree a plus6+ years of hands-on SDLC IT project/program management<br />• Experience working in an IT PMO is a plus<br />• Proven ability to lead groups, manage project deliverables, and maintain client relationships<br />• Experience in managing budgets, project plans, resource allocations, and priorities.<br />• MS Suite, Visio, expertise with Excel, MS Project<br />• Demonstrated skills with portfolio and project management tools such as HP PPM, is a plus.<br />• Demonstrated expertise with various industry PM methodologies including AGILE, SCRUM, RUP, Waterfall, PMI PMBok, PMP Certified<br />• Exposure to multiple, diverse technologies across a large, global environment.<br />• Exceptional interpersonal skills, including teamwork, facilitation and negotiation.<br />• Strong leadership skills.<br />• Excellent analytical and technical skills allowing for quick decision making and direction setting.<br />• Excellent written and verbal communication skills. Multiple languages a plus.<br />• Excellent planning and organizational skills.<br />• Ability to balance the long-term (&quot;big picture&quot;) and short-term implications of individual decisions.<br />• Ability to apply multiple solutions to business problems.<br /><br /></p>",
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