CHANGE CONTROL PROJECT MANAGER

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.
• 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).