The Project Leader II is responsible for driving cross functional New Product Introduction project execution for a product. The project Leader II develops the Integrated Project Plan and leads the team to successfully deliver the project team objectives. He/she ensures that the necessary resources are applied and delivering to plan. In addition the Project Leader II works with a cross-functional team to ensure product manufacturability, serviceability, safety and quality.
- Leading and managing multiple projects within the Core Imaging R&D portfolio to agreed specifications and quality within the approved budget and resources.
- Working closely with all cross-functional groups in delivering the project(s).
- Leading cross-functional project activities.
- Working with the line functions to ensure full compliance with all applicable laws, legislation and regulatory requirements e.g. GLP, GMP and GCP
- Managing quality objectives, regulatory requirements, schedules, and program risks and making decisions based on business objectives
- Forecast and track resources and materials for timely NPI project execution
- Work with core team members to complete monthly reports (financial & status)
- Define core team, scope & functional deliverables. Work with the cross functional team to generate project dashboard (objectives) & review status with team and sponsor
- Hold biweekly project team meetings, issue agendas and actions/decisions. Maintain action/decisions log and other project related documentation (project charter, scope, timelines, etc) in team library.
- Maintain accurate budget & timeline information (cost, time & quality) including best & base case scenarios.
Qualifications/Requirements: 1. BS/MS Degree in Life Sciences, Chemistry, Physics
2. Minimum of 5 years project leadership experience pharmaceutical and/or clinical development
3. Demonstrated leadership of cross-functional project teams and an ability to drive project plans to completion
4. Familiarity with FDA/EMEA/PMDA/CFDA and other regulatory standards and guidelines
5. Demonstrated understanding/experience with the New Product Introduction (NPI) cycle
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics: 1. PhD Degree in Life Sciences, Chemistry, Physics,
2. Strong written and verbal communication skills
3. Experience with conflict resolution
4. Self-starter, energizing, results oriented, and able to multi-task
5. Demonstrated problem solving ability and results orientation. Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues
6. Demonstrated ability to work in a collaborative, matrixed, and customer focused environment
7. Excellent communication, influencing skills and ability to gain buy-in for initiatives
8. Project management certification
9. Demonstrated skills in proactively identifying, facilitating and driving closure of a product
10. Knowledge of GE Healthcare engineering tools and processes
11. Attention to detail and ability work independently toward timely completion of a variety of assignments
12. Ability to develop unique concepts/solutions for complex products