Cell & Gene Therapy Change Control Lead

Katalyst CRO; Boston (MA); On-site; USD 140,000 - 170,000; Full time

Job summary

Katalyst CRO is seeking a Change Control Project Manager to support cross-functional teams executing change controls for biotech programs. You will track scope, timeline and milestones for cell and gene therapy projects, ensuring adherence to GMPs and regulatory requirements.

The ideal candidate brings a strong technical background, excellent communication, attention to detail, and the ability to manage multiple tasks in a matrixed environment across QMS tools and stakeholders.

Qualifications

• Bachelor's degree in engineering, life sciences or related field.
• 8+ years in biopharma or biotech project management.
• Experience with GMPs and drug development lifecycle.
• Ability to manage multiple tasks in a cross-functional environment.
• Excellent written and verbal communication skills.

Responsibilities

• Partner with functional leads to monitor integrated project plans and identify interdependencies and critical path.
• Track milestones and decision points; drive completion of changes.
• Communicate status, risks, and mitigation plans to stakeholders.
• Organize team communications: agendas, minutes, tasks, risk analyses.
• Maintain project status tools: action log and risk register.
• Deliver PM tools and templates for change control activities.
• Operate within SOPs and GxP requirements where applicable.

Skills

Project management

GxP knowledge

Regulatory knowledge

Risk management

Cross-functional

Communication

Education

Bachelor's degree

Tools

Microsoft Project

Power BI

Smartsheet

PowerPoint

SharePoint

Job description

Katalyst CRO is seeking a Change Control Project Manager to support cross-functional teams executing change controls for biotech programs. You will track scope, timeline and milestones for cell and gene therapy projects, ensuring adherence to GMPs and regulatory requirements.

The ideal candidate brings a strong technical background, excellent communication, attention to detail, and the ability to manage multiple tasks in a matrixed environment across QMS tools and stakeholders.