Senior Manager/Director, Project Management - AID

Werfen•San Diego, CA

8d•$175,000 - $210,000

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. The Head of , Project Management Office (PMO) is responsible for leading and managing the PMO in the Autoimmunity Headquarter and Technology center . 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. Participate s in business strategic planning , representing current and planned projects needed to implement the business strategy. Provide s 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.

Requirements

BS Degree, MS/MBA preferred, in a technical or management discipline
Requires full and comprehensive knowledge of the complete product lifecycle, including all aspects of product development from conception to manufacturing in IVD insustry
Fifteen years product development experience, including eight years in successful technical leadership, project coordination, or project management are required.
Experience in the development and release of at least one successful product launch of a medical device product is required.
Business Acumen; Technical Skills; Process Management; Strong organization and planning skills
Strong oral and written communication skills
Stakeholder management and Leading in a matrix
Building Talent Planning and supporting the development of individuals’ knowledge, skills, and abilities so that they can fulfill current or future job responsibilities more effectively.
Customer Focus Ensuring that the internal or external customer’s perspective is a driving force behind strategic priorities, business decisions, organizational processes, and individual activities; crafting and implementing service practices that meet customers’ and own organization’s needs; promoting and operationalizing customer service as a value.
Decision Making Identifying and understanding problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; choosing the best course of action by establishing clear decision criteria, generating and evaluating alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences.
Driving for Results Setting high goals for personal and group accomplishment; using measurement methods to monitor progress toward goals; tenaciously working to meet or exceed goals while deriving satisfaction from that achievement and continuous improvement.
Driving Innovation Creating an environment (culture) that inspires people to generate novel solutions with measurable value for existing and potential customers (internal or external); encouraging experimentation with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions.
Emotional Intelligence Essentials Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.
Effectively carries out the expectations of Werfen People Managers as defined in Werfen’s Role of the Manager program. Among others this includes maintaining regular, at minimum once a month, and transparent communication with the team through effective use of formal one-on-one meetings with direct reports and team meets.
Managing performance issues and conflict proactively; uses judgement in consulting with department leadership and Human Resources.
Responsibility for the team´s compliance in terms of trai ning, and fulfilment of their tasks and objectives as well as onboarding of new employees and development of the existing team.

Nice To Haves

PMP certification is preferred additional course work in accounting, business economics, resource management and project management is desired.

Responsibilities

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.
Establishes , defines and maintains the project management system and processes.
P rovide s 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.
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.
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.
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.
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 .
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.
Regularly interacts with senior management, customers and regulatory agencies concerning program status and strategic planning.
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 .