
Program Manager, Assay Development
- Solna, Stockholm
- Permanent
- Heltid
- Lead the planning and implementation of multiple assay development programs including definition of project scope, goals, deliverables, project tasks and resource requirements.
- Manage Design History File and project documentation.
- Lead daily/weekly stand-ups and meetings providing direction and support to project team, to track and ensure on time delivery, including risk prevention, identification and management.
- Manage communication effectively with external and internal stakeholders including leadership report-outs and decision support, and leading by influence for cross-functional coordination and effectiveness.
- Drive continuous improvement of cross-functional product development processes.
- Minimum 3 years of direct project management work experience with innovation or product development within the Life Science or Molecular Diagnostics field.
- Proven experience in Quality System Regulations (QSR) 21 CFR 820; Design Control: ISO 13485:2003.
- Working knowledge of quality documentation management systems within a regulated industry.
- Demonstrated experience organizing and leading workshops.
- Demonstrated effective written and oral communications skills in both English and Swedish.
- Ability to travel up to 20% of the time.