As a Project Manager at Cepheid you will be leading cross-functional teams to support new product development of In Vitro Diagnostic assays. In this role you must be result driven, able to understand key business drivers and use this understanding to facilitate project scope, targets and deliverables while managing the project team.
To succeed in this role you must have excellent communication skills and comfortable to cooperate with persons at different organizational levels. You should be detail oriented, data driven, and can handle multiple tasks under tight deadlines. You will support project administration, tracking, reporting and other project related activities to ensure on time delivery of projects within budget constraints.
• Coordinate project activities in cross-functional teams to support new product development of In Vitro Diagnostic assays
• Facilitate the definition of project scope, goals, and deliverables
• Develop full scale project plan including project tasks and resource requirements
• Track and ensure on time delivery of project deliverables
• Identify, prevent and manage risks
• Manage Design History File and project documentation
• Lead daily/weekly stand-ups and meetings providing direction and support to project team
• Manage communication with external and internal stakeholders
• Align the company’s general business targets with the project’s objectives and outcomes
• Contribute to improvement and implementation of cross functional internal processes
• Engage in PMO development through supporting and driving implementation of best industry practice and innovation within project management.
• Support You would be part of a newly formed PMO and the expectations are that a successful candidate will be fully engaged in PMO development activities besides project leading responsibilities or something like this.
Required Knowledge, Skills, and Abilities:
• MSc degree is required or higher within Life Sciences, Molecular Biology, Chemistry, and/or a technical discipline
• MBA or Strategic Management background will be given priority
• 3+ years working experience with innovation or product development within the Life Science field
• 5+ years of experience as Project Coordinator/Project Manager or similar position
• Experience in work with virtual and dispersed project teams
• Strong written and verbal communication skills
• Highly organized, quality conscious and self-driven
• Ability to handle multiple tasks under tight deadlines
• Fluency in English in both written and verbal communication
• Experience from working in a FDA or ISO 9001 compliant setting (preferably IVD/Medical Devices)
• Experience in Quality System Regulations (QSR) 21 CFR 920; Design Control: ISO 13485:2003
• Medical device and/or In Vitro Diagnostic product launch experience is highly preferred
• Familiar with design control in a regulated environment
: Project/Program Management
: EMEA-Western Europe-Sweden-Stockholm-Solna