Director, Project Management, Medical Devices & Diagnostics

Overview

Job Summary

The Director, PMO will report directly into the COO, will serve as a member of the Executive Management team and will be responsible for leading and managing the project management function for the Autoimmunity division. This individual has oversight of product related projects within the business. Ensures effective project management methodology is deployed and used throughout the business for product development and life-cycle management (on-market). Monitors project performance and ensures that all key projects are being executed to Scope, on time and within budget.Identifies  both trends in project management practices and risks in specific projects  that need to be resolved. Coordinates with the functional managers and executives to ensure resource are allocated in the best manner to optimized business and project results. Collaborates with other Werfen entities on best practices of project management. Works to continiuously increase the maturity level of the PMO towards a strategic project management office (sPMO). Ensures all work is carried out in accordance with Autoimmunity’s Quality Management System as well as all of administrative and regulatory requirements.

Participates in business strategic planning, representing current and planned projects needed to implement the business strategy. Provides direct and/or indirect supervision to members of the management team and/or members of the PMO. Position requires strong, cross-functional leadership skills in a highly technical medical device product development environment.  

Responsibilities

Key Accountabilities

• Technical and Program Leadership: Provide general oversight and leadership to all product development projects. Responsible to assign project managers to all product development projets and other strategic project as defined by the senior management team.
• Project Management Process: Establishes, defines and maintains the project management system and processes. Provides direction to the Project Sponsor with respect to the project scope,  objectives, deliverables and measurements for the product development project management methodology. Works with project managers to define project team composition, meeting structure and caidance. Conduct regular reviews of the program / project portfolio of all product development projects to ensure business objectives will be met. Work with the Project Sponsors to continually improve the product development project management methodology.
• Program Planning, Execution and Control: Periodically review project plans (scope, timeline and budget) and status to ensure the application of best practices for project management and the efficacy of the product development project management methodology. Periodically review the status of the portfolio of development projects and programs with other members of the senior management team.
• Strategy Development: Participates with senior management in mid- to long-term strategy related to new areas of scientific and technological research and development. Originates major new ideas for company projects and programs.
• Risk Management: Oversees project risk management from project planning to completion. This includes but is not limited to baseline risk analysis and mitigation. Periodically review project risk drivers and actions to identify trends. Implement organizational and process changes to reduce overall project risk.
• Design Control: Oversees the creation and maitainance of all elements required for Design Control procedure. This includes management according to our design control procedure using a phase gate approach.
• Business Management: As a member of the business management team, provide plans and status updates concerning product development and life-cycle management projects that support the business. Participate with other senior management team to make the best use of resources among the competing business needs. Ensures that an adequate pool of equipment and resources are available to meet the needs of the projects within the business constraints. Prepares and manages department budgets.
• Communication: Regularly interacts with senior management, customers and regulatory agencies concerning program status and strategic planning.
• Supervision and Employee Performance: Leads and manages the PMO team, including people managers and individual contributors. Responsible for hiring and developing a high performance team.  Role models Werfen Values and ensures compliance with company policies.   

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key Relationships