About this role
The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy T1D team. RESPONSIBILITIES Partner closely with functional area leads, maintain and actively monitor integrated project plans.
Identify/communicate interdependencies as well as critical path activities for the project(s) Track and monitor key milestones and decision points and work with project team members to drive the completion of changes. Effectively communicate with internal team members and key stakeholders on the status, objectives, risks, and mitigation plans associated with change control projects. Organize and maintain team communications including meeting agendas, minutes, tasks lists, and risk analyses/mitigation strategies.
Update and maintain project status tools, such as a project action log and risk register. Develop and deliver project management tools and templates to manage change control team activities. Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable
Bachelor’s degree in engineering, life sciences or related field. A minimum of 8 years of experience in the biopharmaceutical industry. A minimum of 6 years of experience in project management of biopharmaceutical product Working knowledge of biotechnology, GMPs, and drug development lifecycle.
Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively. Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g., Smartsheet, Power BI, etc.).
Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization. Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective. Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10) Understanding of risk assessment.
MUST HAVE: Proven history in managing and driving project success within the biotech industry. Strong technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, and willingness to pivot as priorities change. Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset.
1- year contract with possible extension Administrative shift Overtime availability