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Company Contact Info
- San Diego, CA
- Alere, Inc.
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Senior Project Manager - Cardio Metabolic
ALERE • San Diego, CA
Posted 30 days ago
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The Senior Project Manager (PM) reports directly into the Cardio Metabolic Business Unit Program Management Office (CM PMO). In this position, the PM is responsible for leading cross functional core teams, managing the development and implementation of new products under the established Product Development Governance (PDG) process. This person is also responsible for supporting the implementation of major initiatives and processes led by the PMO.In compliance with the company's Product Development and Commercialization processes, the Senior Project Manager will lead approved projects through the phase gate approval process. Because products are for In Vitro Diagnostics (IVD), the PM will contribute to the definition of project strategy to deliver products that meet applicable regulations of the FDA, ISO 13485, and other international standards products.
Tasks and responsibilities
- Provides project management expertise for small to medium scale projects that may span across sites and/or business units.
- Leads a multi-functional core team from Concept through Launch; through proper execution of Design Controls that includes efficient transfer of product from Global R&D to manufacturing and global marketing through post release to achieve project closure at Gate 5;
- Works closely with various disciplines within R&D and Marketing, Clinical, Quality, Regulatory, Manufacturing, and establishes project plans and objectives;
- Bridges the gap between strategy and tactical execution at the project level. This position requires knowledge and experience in effectively managing diverse disciplines, cultures, locations, personalities, communication styles, conflicting priorities and/or requirements.
- Develops cost analysis, creates and manages the integration of project schedules, project budget;
- With the enterprise organizations, resolves resource allocation issues, conflicts, and priorities to ensure the project is staffed appropriately, completed on time, and within budget constraints.
- Tracks progress and communicates proactively the impact of changes (e.g. scope, cross functional resources, timelines, costs, etc.) to key stakeholders.
- Ensure that teams are equipped and prepared per the appropriate PDG phase requirements to present at key business and design review meetings; that all appropriate stakeholders within and outside the BU are apprised of review meetings and the results thereof.
- Manage the process for device integration acceptance into the corporate platform(s).
- Ensures that CTQ's (Critical to Quality) and KPIV's (Key Process Input Variables) are well defined, reviewed and implemented for the project.
- Ensures that Design Reviews for system readiness include all appropriate stakeholders outside of the sub-system or individual device.
- Ensures that the Acceptance criteria for system level integration are completely aligned with the design and project management requirements for integration. Facilitate team process needed to meet requirements to demonstrate system level integration readiness.
- Ensures the timely collaboration and coordination of design requirements, cross functional resourcing, and scheduling between projects, sites, and platform/system level organizations.
- Support the BU's strategic planning and prioritization process by coordinating and providing specific project information (e.g. project descriptions, effort assessment, labor and cost requirements, etc.).
- Support the budget planning process for both existing and candidate projects. Coordinates appropriate meetings and collaboration needed to support PMO's resource allocation and planning process.
- Delivers presentations at PAC meetings, Program Reviews, and publishes the BU's monthly project dashboards, and messaging.
- Leads the teams through best practices in planning such as scrum, creating work breakdowns, schedule development, and critical chain analysis.
- Provide training or mentorship to the core team and other project leaders in order to elevate efficiencies and facilitate compliance to the Product Development Governance and Design Change Processes.
- Works with Design Quality and ensures that all DHF's are complete and assessed for quality and completeness at each phase of product development.
- Assist in establishing project metrics aligned with the standards and guidance provided by corporate PMO.
- Perform other duties & projects as assigned.