The Project Manager is responsible for the implementation of strategic development projects and any other projects or initiatives as assigned. Specific responsibilities include schedule and budget development, resource estimation, risk identification and mitigation and tracking and management of internal/external communication, as appropriate. Additionally, personnel resource management, primary or supporting role in lean initiatives, supplier sourcing and product standardization.
1. Oversee the development, design, coordination, implementation, analysis, reporting, and maintenance of project plans.
2. Participate in the establishment of corporate-wide systems, procedures and structure that facilitate efficient project management throughout the organization. Also responsible for driving early adoption of new systems and project tools by team members.
3. Manage personnel, activities and budgets associated with assigned project teams.
4. Lead project team meetings and ensure that the team is provided routine project updates such as meeting minutes and project updates.
5. Interface, collaborate and communicate with Operations, Process Engineering, R&D, Quality Engineering, Quality Assurance, Finance, Marketing and MTF Management on all phases of a project plan.
6. Develop and maintain milestones, timelines, risk mitigation, goals and objectives for assigned projects.
7. Provide Management with updates on assigned project activities as necessary or required.
8. Plan and execute cross functional projects according to defined deadlines, this includes management of the entire PM lifecycle including business case development, scoping, and resourcing.
9. Provide feedback to departmental managers / supervisors related to personnel assigned to project teams.
10. Ensure the completion of project documentation in compliance with internal procedures and statutory requirements (e.g. Design History File, Design Dossier, etc.).
11. Participate in and/or leads project-related discussions with MTF’s distribution partners as required for projects. May perform technical training of MTF or distribution partner personnel (marketing, sales, technical support) as required.
12. Coordinate with other respective departments to advance cross functional initiatives.
13. Lead the successful implementation of a project in collaboration with management and stakeholders according to specified goals.
14. Assist on special projects and performs additional duties as assigned. (exempt) (non-exempt)
15. Coordinate with Regulatory Affairs and Quality Assurance to assure the assigned projects comply with cGMP, QSR, GTP, FDA and AATB Standards and other applicable standards.
Supply Chain Specific:
16. Drive continuous process improvements and value analysis projects as part of Lean/Standardization initiatives.
17. Lead vendor development and improvement projects as well as vendor outsourcing initiatives to further advance Operations initiatives.
18. Manage critical suppliers as part of the strategic supplier program.
19. Participate in and or lead contract negotiations as part of contract management.