Change Control Project Manager

Job Title: Change Control Project Manager
Location: Boston, MA
Job Type: Contract
Industry: Biopharmaceutical / Cell & Gene Therapy

We are seeking an experienced Change Control Project Manager to support cross-functional project teams executing change controls within a biopharmaceutical environment. The Project Manager will be responsible for tracking and reporting project scope, timelines, milestones, risks, and deliverables associated with the Cell & Gene Therapy Type 1 Diabetes (T1D) team.

The ideal candidate will have a strong technical background, extensive biopharmaceutical project management experience, solid knowledge of GMP requirements, and an understanding of the drug development lifecycle through commercialization. Experience with cell and/or gene therapy and risk management is highly desirable.

• Partner with functional area leads to maintain and actively monitor integrated project plans.

• Identify and communicate project interdependencies and critical-path activities.

• Track key milestones, decision points, deliverables, and timelines.

• Work with cross-functional project team members to drive timely completion of change controls.

• Communicate project status, objectives, risks, issues, and mitigation plans to internal teams and key stakeholders.

• Organize and maintain project communications, including meeting agendas, meeting minutes, action items, and task lists.

• Develop and maintain risk analyses, mitigation strategies, project action logs, and risk registers.

• Develop and implement project management tools and templates to support change-control activities.

• Manage multiple priorities while adapting to changing project requirements and business needs.

• Ensure project activities are performed in accordance with established SOPs and applicable GxP requirements.

• Facilitate cross-functional meetings and provide clear project updates to stakeholders at various organizational levels.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

• 8 years of experience in the biopharmaceutical industry.

• 6 years of project management experience within biopharmaceutical product development/manufacturing.

• Strong working knowledge of biotechnology, GMPs, and the drug development lifecycle through commercialization.

• Experience managing change control projects in a regulated biopharmaceutical environment.

• Strong understanding of risk assessment and risk mitigation.

• Strong knowledge of regulatory requirements, including FDA, 21 CFR Part 211, EU GMP, and ICH Q10.

• Proven ability to work effectively within cross-functional and matrixed organizations.

• Strong analytical, problem-solving, and critical-thinking skills.

• Excellent written and verbal communication skills.

• Strong presentation, facilitation, and stakeholder-management skills.

• Ability to prioritize multiple projects and balance competing priorities.

• Experience with Cell & Gene Therapy (CGT) methodologies.

• Experience supporting T1D / diabetes-related cell therapy programs is a plus.

• Experience with project management tools such as Microsoft Project, Smartsheet, Power BI, or SharePoint.

• Strong proficiency with Microsoft Office Suite, including Project, PowerPoint, SharePoint, Word, Excel, and Outlook.