We are seeking a Change Control Project Manager for a 6+ month contract position based in Boston, Massachusetts. In this role, you will support cross-functional project teams executing change controls within a cell and gene therapy program, tracking and reporting on project scope, timeline, and milestone status. You will need to demonstrate a detail-driven approach, a proven track record of managing project success in the biotech industry, a strong technical background, solid working knowledge of GMPs, and an understanding of the drug development pathway through commercialization.
Responsibilities
Partner closely with functional area leads to maintain and actively monitor integrated project plans, identifying and communicating interdependencies and critical path activities.
Track and monitor key milestones and decision points, working with project team members to drive completion of changes.
Communicate effectively with internal team members and key stakeholders regarding project status, objectives, risks, and mitigation plans associated with change control projects.
Organize and maintain team communications, including meeting agendas, minutes, task lists, and risk analyses and mitigation strategies.
Update and maintain project status tools, such as project action logs and risk registers.
Develop and deliver project management tools and templates to manage change control team activities.
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Perform duties consistently within established SOPs and in accordance with GxP requirements, where applicable.
Qualifications
Required
Bachelor's degree in engineering, life sciences, or related field.
Minimum 8 years of experience in the biopharmaceutical industry.
Minimum 6 years of experience in project management of biopharmaceutical products.
Working knowledge of biotechnology, GMPs, and the drug development lifecycle.
Ability to work effectively in cross-functional, matrixed environments, prioritizing and managing multiple tasks simultaneously while integrating cross-functional issues and balancing competing priorities.
Expertise in Microsoft Office suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook).
Excellent oral and written communication skills, including presentation and facilitation capabilities, to effectively communicate updates and issues across organizational levels.
Strong analytical, problem-solving, and critical thinking skills with the ability to combine attention to detail with big-picture perspective.
Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10).
Understanding of risk assessment.
Preferred
Knowledge and/or experience with cell and gene therapy methodologies.
Experience with additional project management tools (e.g., Smartsheet, Power BI).
