21 CFR part 11 Project Manager / Program Manager

PM with 21 CFR 11 (Electronic Records; Electronic Signatures) experience


Location: Carlsbad, CA

Deliverables:

• 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 HP 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.

All your information will be kept confidential according to EEO guidelines.