Biotech Change Control Project Manager

Vertex Pharmaceuticals; Boston (MA); On-site; USD 80,000 - 90,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Change Control Project Manager to support cross-functional project teams and manage change controls for cell and gene therapy programs. The role requires a strong technical background, GMP knowledge, and excellent communication within a matrixed organization.

The position emphasizes risk management, detailed project tracking, and development of templates/tools for change control activities. This is a temporary assignment through a third-party agency partner.

Qualifications

• Bachelor’s degree in engineering, life sciences or related field.
• A minimum of 8 years of experience in the biopharmaceutical industry.
• A minimum of 6 years of experience in project management of biopharmaceutical product
• Working knowledge of biotechnology, GMPs, and drug development lifecycle.
• Ability to work effectively in cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously, integrating cross-functional issues and balancing competing priorities effectively.
• Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools a plus (e.g., Smartsheet, Power BI, etc.).
• Excellent oral and written communication skills, including presentation and facilitation skills, to effectively inform key updates & issues across all levels of the organization.
• Strong analytical, problem solving and critical thinking skills, including an ability to combine attention to detail with a big picture perspective.
• Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10)

Responsibilities

• Partner closely with functional area leads, maintain and actively monitor integrated project plans. Identify/communicate interdependencies as well as critical path activities for the project(s)
• Track and monitor key milestones and decision points and work with project team members to drive the completion of changes.
• Effectively communicate with internal team members and key stakeholders on the status, objectives, risks, and mitigation plans associated with change control projects.
• Write Risk Assessments
• Organize and maintain team communications including meeting agendas, minutes, tasks lists, and risk analyses/mitigation strategies.
• Update and maintain project status tools, such as a project action log and risk register.
• Develop and deliver project management tools and templates to manage change control team activities.
• Consistently perform duties within established SOPs, and in accordance with GxP requirements, where applicable

Skills

Project management

Cross-functional collaboration

Regulatory understanding

Communication

Attention to detail

Risk management

Education

Bachelor's degree in engineering or life sciences

Tools

Microsoft Project

PowerPoint

SharePoint

Word

Excel

Outlook

Power BI

Job description

Vertex Pharmaceuticals is seeking a Change Control Project Manager to support cross-functional project teams and manage change controls for cell and gene therapy programs. The role requires a strong technical background, GMP knowledge, and excellent communication within a matrixed organization.

The position emphasizes risk management, detailed project tracking, and development of templates/tools for change control activities. This is a temporary assignment through a third-party agency partner.