Thorne needs a Software Program Manager to be responsible and accountable for all new and existing regulatory software systems used at Thorne’s manufacturing locations, overseeing the planning, execution, and support of the software lifecycle while ensuring compliance with regulatory requirements.
Requirements
- Demonstrates skills utilizing project management tools and methodologies.
- Experience in an FDA regulated environment and familiarization with Quality Management processes, computerized software systems and terminology is required.
- Experience with computerized software development and validation life cycle is required.
- Experience with Quality Management, Laboratory Information Management, Learning Management, Manufacturing, and Electronic Batch Records software systems.
Responsibilities
- oversees the planning for and execution of technical application design, configuration, testing, implementation, and on-going application support and compliance for the software lifecycle.
- manages the personnel who implement, support, and validate new and existing regulated software systems.
- Coordinates and works with management and subject area experts in the planning for, and execution of regulated information technology capabilities to improve the operations, productivity and outcomes of Thorne’s Manufacturing and Quality functions and their day-to-day activities.
- Collaborates with in-house and third-party developers, quality assurance, quality control, production support, and others as required to provide technical direction on systems analysis, gathering of requirements, design, development, testing and deployment.
- Facilitates documentation of technical requirements, software design sessions, process workflow definitions and systems architectural reviews as well as implement necessary change control procedures.
- Ensures the timely and effective delivery of planned solutions into ongoing daily activities.
- Coordinates and/or perform validation of various modules as they are implemented.
Other
- The Software Program Manager must be able to lead and work with cross-functional teams and track projects to completion.
- This position requires experience in cGMP manufacturing environment plus demonstrate familiarity with software regulatory compliance and validation, quality concepts, practices, and procedures.
- 4-year college degree with four to eight years related experience; or equivalent combination of education and experience is required.
- 3 years of management experience.
- Meets stated deadlines while managing multiple projects and activities.
