Change Control Project Manager

IT MINDS L.L.C.; Boston (MA); On-site; USD 90,000 - 120,000; Part time

Job summary

IT MINDS L.L.C. is seeking an experienced Change Control Project Manager to support cross-functional teams in a biopharmaceutical setting. You will track scope, timelines, milestones, risks, and deliverables for GMP-compliant change controls on the CGT T1D program.

The role requires a strong technical background, extensive project management experience in regulated biopharma, and solid knowledge of GMPs and the drug development lifecycle through commercialization.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Project management

Cross-functional teamwork

Communication

Analytical thinking

Time management

Education

Bachelor's degree in Engineering, Life Sciences, or related technical field

Tools

Microsoft Project

Smartsheet

Power BI

SharePoint

MS Office Suite

Job description

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

Job Description

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.

Key Responsibilities

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.