As a Senior Program Manager you will lead the project core team for a fast moving, complex, multi-site integrated in vitro diagnostics program.
The Program Manager will contribute to the definition of project strategy and guide the core team from program inception to product commercialization, including planning, execution and all aspects of the product life cycle. The ideal candidate has experience leading integrated project teams that include reagent, automation and software development, manufacturing, clinical, regulatory and commercial team members in a fast-paced, regulated environment. The high visibility program demands crisp communication among functions and executive partners.
- Leadership of global cross-functional core teams for in vitro diagnostic products
- Creates, maintains, and organizes necessary documentation and records; responsible for the quality of project deliverables and documentation
- Oversees and prepares project team budget including resources and costs, collaborating with Finance and other cross-functional departments
- Identifies, documents, and communicates project risks and contingency plans
- Tracks and communicates project status, plans, issues, timelines, action items, and budgets
- Communicates, documents, and archives project team activities and decisions; acts as a primary contact for project team related information
- Facilitates project team meetings, cross-functional communication and decision making, ensures alignment with internal and external stakeholders
- Exercises scope and change management with consideration for the customer, team, and company needs
- Mentoring of project team members in business and quality practices
- Promotes a proactive, professional culture within the Program Management Office, contributing to the group’s success
- Contributes material and timely input to the development and continuous improvement of the Program Management Office processes, related SOPs, and supporting materials
This job is intended for employees who lead projects full- time (not program managers who may periodically lead projects within their own functional area).
- Bachelor’s degree in life sciences, engineering, or related field or equivalent experience
- 8 years of Project Management experience, including large, complex programs that include reagents, software and automation as components
- Experience leading in vitro diagnostic development and commercialization programs preferred
- Strong understanding of product development challenges and methods for resolution
- Advanced understanding and ability adhere to established quality standards and regulatory compliance requirements for medical device or diagnostics like CFR 21, ISO 13485, Design Control
- Proven ability to successfully lead program teams from concept to market
- Ability to resolve day-to-day issues and develop mitigation plans
- Demonstrated skills using advanced level MS Project or related software for Project Management
- Solid skills using MS Office suite, Outlook
- PMP (Project Management Professional) certification is a plus.