Change Control Project Manager, Manufacturing Technical Operations

Position: Change Control Project Manager (Manufacturing Technical Operations)
Location: Onsite in Boston, MA
Duration: 12-Month Contract

General Position Summary

The Change Control Project Manager will support cross-functional project teams executing change controls within a biopharmaceutical environment. The Project Manager will track and report project scope, timelines, milestones, risks, and deliverables across cell and gene therapy programs.

The ideal candidate is detail-oriented with a proven history of managing and driving project success within the biopharmaceutical industry. This individual should have a strong technical background, solid working knowledge of GMPs, an understanding of the drug development lifecycle through commercialization, and the ability to adapt as priorities change.

Experience with cell and gene therapy methodologies and risk management is highly valued.

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 and decision points and drive timely completion of change activities.

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

• Organize team communications, including meeting agendas, minutes, action-item lists, and risk analyses.

• Maintain project action logs, risk registers, and other project status tools.

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

• Perform responsibilities in accordance with established SOPs and applicable GxP requirements.

Qualifications

• Bachelor's degree in engineering, life sciences, or a related field.

• Minimum 8 years of experience in the biopharmaceutical industry.

• Minimum 6 years of experience in biopharmaceutical product project management.

• Working knowledge of biotechnology, GMPs, and the drug development lifecycle.

• Experience working effectively in cross-functional, matrixed environments.

• Ability to prioritize and manage multiple projects while balancing competing priorities.

• Advanced proficiency with Microsoft Project, PowerPoint, SharePoint, Word, Excel, and Outlook.

• Experience with additional project management tools such as Smartsheet or Power BI is a plus.

• Excellent written and verbal communication, presentation, and facilitation skills.

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

• Ability to maintain strong attention to detail while understanding the broader project perspective.

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

• Understanding of risk assessment and risk mitigation principles.

• Knowledge or experience with cell and gene therapy methodologies is a plus.