The Project Manager manages projects by providing the support and technical assistance to COO (Chief Operations Officer). The individual must be capable of being self-managed and maintaining a high degree of professionalism at all times. Strong communication and interpersonal skills are a must. As a Project Manager, individual will be a liaison between COO, KORU stakeholders, and the CMOs (Contract Manufacturing Organization) during the contract manufacturing transfer, as well as the dedicated point of contact. Project Manager will take direction from the COO as it relates to strategic corporate goals.
The ideal candidate must have strong project management skills, strong manufacturing background, ability to accurately read and review product specifications, have strong interpersonal skills, and a desire to work directly with CMO on contract manufacturing transfer issues. The ability to multitask is a must, in addition to being proactive with all open issues related to project scope. Project Manager’s will be involved in all stages of the contract manufacturing transfer project.
Essential Job Functions
- Responsible for planning and tracking projects, managing and allocating resources, and carrying projects from kick-off through final execution.
- Manage priorities with focus in intercepting distractions that could take projects off track.
- Create project schedules, track and ensuring all deliverables are being met and regularly communicate status with all internal and external team members.
- Support the COO in effectively outsourcing manufacturing operations to CMO, including supporting stakeholders.
- Overseeing the transfer of manufacturing equipment and processes to ensure product meets required product performance requirements and associated specifications.
- Ensure all products manufactured at CMO meet company established product specifications by enforcing SOPs, DMRs and cGMP standards as required by the Quality Systems regulations – CFR 820 and ISO 13485 regulations.
- Bachelors in business management, management or industrial technology, or a BS in Engineering
- 5-10 years of project management experience with 5+ years of experience directly in co-manufacturing environment or managed co-manufacturing partners in medical device industry. (PMP certification required)
- Expert proficiency in MS Office and technology; preferred fluency in MS Project program
- Excellent communication and presentation skills both verbal and written
- Must possess strong and proven people management skills, including resolving conflict, and developing others, promoting teamwork, and performance management
- Proven leadership skills in achieving project objectives and deliverables
- Track record that demonstrates personal initiative, innovative problem solving and the capability to overcome challenges
- Approximately 10%-25% domestic and international travel to CMO’s sites
- Bi-lingual; ability to read, write and understand Spanish preferred
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