Project Manager Pmo

JOB OBJECTIVES

The project manager is responsible for aligning the multidisciplinary project teams. He provides the direction, progress, coordination and support necessary for the successful initiation, planning, execution, monitoring and closing of out-licensing, in-licensing, technology transfer and new development projects.

PRIMARY FUNCTIONS

• Ensure that projects are properly initiated (Kick off / project charter) and that the technical information necessary for out-licensing, in-licensing, transfer projects or new developments has been provided by the client.
• Develop and update detailed project plans encompassing the project scope through the overall implementation of the project.
• Evaluate and optimize the time needed to complete the different stages of a project.
• Coordinate all required project documentation.
• Establish key milestones consistent with regulatory guidelines.
• Track operational and capital expenditure for each project.
• To be a leader for the multidisciplinary teams by ensuring the coordination of the projects and the support of the teams during their execution.
• Ensure the collaboration with various departments – production, validation, QA, QC, Pharm Dev, TT, RA, SA for the success of the project.
• Proactive communication of key project information to all relevant stakeholders.
• Ensure effective communication of project timelines, progress and requirements to all project team members and stakeholders.
• Identify, escalate and track project risks that may disrupt the progress of the project.
• Communicate concerns regarding timeline and scope changes to the management team
• Meet and maintain compliance with GMP guidelines.
• Perform any other related tasks deemed relevant to the position.

REQUIREMENTS AND SKILLS

• Bachelor of Science.
• 3 to 5 years in Project Management, experience in the pharmaceutical field is an asset.
• Experience and good understanding of manufacturing and/or R&D.
• Good knowledge of Canadian (Health Canada) and American (FDA) regulations, ICH Guidelines and ability to interpret policies and guidelines.
• PMP certification is an asset.
• Excellent English oral and written communication skills.
• Ability to coordinate and follow-up the steps of several projects in parallel.
• Proficiency in Ms Project and/or Smartsheet.