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Project Manager with 21 CFR 11 (Electronic Records; Electronic Signatures)
Ref No.: 17-29401
Location: Carlsbad, California
  • Oversee all aspects of project scope, schedule, resource, risks and overall management to ensure and drive successful delivery.
  • Ensure the software development and project management deliverables and milestones in project plans are achieved within cost, schedule, scope, and quality.
  • Assure that the project teams are managing the system development process including systems analysis, technical design, coding, testing, turnover to production, user acceptance criteria.
  • Conduct proper and timely communications, change management, and training per project stakeholders and needs.
  • Provide overall capital and operating expense project budget responsibility for multiple projects.
  • Manage critical supplier and internal customer relationships.
  • Maintain extensive knowledge and expertise in project management disciplines, as well as multiple business processes and/or technical areas.
  • Experience supporting different cross-functional applications projects
  • Any experience in CRM, ERP, Validation applications, Financial area, etc. is desirable.
  • Leverage industry best practices to plan, manage, monitor and report on all projects
Skills and Credentials:
  • Bachelor'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
  • Experience working in an IT PMO is a plus
  • Proven ability to lead groups, manage project deliverables, and maintain client relationships
  • Experience in managing budgets, project plans, resource allocations, and priorities.
  • MS Suite, Visio, expertise with Excel, MS Project
  • Demonstrated skills with portfolio and project management tools such as Client PPM, is a plus.
  • Demonstrated expertise with various industry PM methodologies including AGILE, SCRUM, RUP, Waterfall, PMI PMBok, PMP Certified
  • Exposure to multiple, diverse technologies across a large, global environment.
  • Exceptional interpersonal skills, including teamwork, facilitation and negotiation.
  • Strong leadership skills.
  • Excellent analytical and technical skills allowing for quick decision making and direction setting.
  • Excellent written and verbal communication skills. Multiple languages a plus.
  • Excellent planning and organizational skills.
  • Ability to balance the long-term ( "big picture ") and short-term implications of individual decisions.
  • Ability to apply multiple solutions to business problems.