Biotech Change Control Project Lead

Creative Solutions Services, LLC; Boston (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Change Control Project Manager to support cross-functional teams executing change controls within a biopharmaceutical setting. You will track scope, timelines and milestones, driving changes in GMP-compliant processes.

The role requires a strong technical background, knowledge of GMPs and the drug development lifecycle, and excellent communication to manage multiple priorities in a matrixed organization.

Qualifications

• Bachelor's degree in engineering, life sciences or related field.
• 8+ years of experience in biopharmaceutical industry.
• 6+ years of experience in project management of biopharmaceutical products.
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environment.
• Proficiency with Microsoft Office tools (Project, PowerPoint, SharePoint, Word, Excel, Outlook) and PM tools (Smartsheet, Power BI).
• Excellent oral and written communication skills, including presentation and facilitation.
• Strong analytical, problem solving and critical thinking skills.
• Understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10).
• Understanding of risk assessment.

Responsibilities

• Partner closely with functional area leads, maintain and monitor integrated project plans.
• Identify interdependencies and critical path activities for projects.
• Track and monitor milestones and decision points to drive completion of changes.
• Communicate status, objectives, risks, and mitigation plans to stakeholders.
• Organize team communications: meeting agendas, minutes, tasks lists, risk analyses/mitigation strategies.
• Update project status tools: action log and risk register.
• Develop and deliver PM tools and templates for change control activities.
• Perform duties within SOPs and GxP requirements where applicable.

Skills

Project management

Cross-functional teams

Risk management

Communication skills

GxP

Education

Bachelor's degree

Tools

Microsoft Project

PowerPoint

SharePoint

Excel

Power BI

Job description

Creative Solutions Services, LLC is seeking a Change Control Project Manager to support cross-functional teams executing change controls within a biopharmaceutical setting. You will track scope, timelines and milestones, driving changes in GMP-compliant processes.

The role requires a strong technical background, knowledge of GMPs and the drug development lifecycle, and excellent communication to manage multiple priorities in a matrixed organization.