Project Manager, Change Control

Temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals.

About the role

The Project Manager, Change Control supports cross-functional project teams executing change controls. This role tracks and reports project scope, timeline, and milestone status for the cell and gene therapy T1D team. The ideal candidate is detail-driven with a proven history in managing and driving project success within the biotech industry, a strong technical background, and a solid working knowledge of GMPs. An understanding of the drug development pathway through commercialization and the ability to pivot as priorities change are essential. Knowledge or experience with cell/gene therapy methodologies and a strong understanding of risk management are assets.

Responsibilities

• Partner closely with functional area leads, maintain and actively monitor integrated project plans.
• Identify and communicate interdependencies as well as critical path activities for the project(s).
• Track and monitor key milestones and decision points; 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, task 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.

Requirements

• Bachelor’s degree in engineering, life sciences, or a 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 products.
• Working knowledge of biotechnology, GMPs, and the drug development lifecycle.
• Ability to work effectively in a cross-functional, matrixed environment, prioritizing and managing multiple tasks simultaneously.
• Expertise in Microsoft suite (Project, PowerPoint, SharePoint, Word, Excel, Outlook). Experience with other PM tools (e.g., Smartsheet, Power BI) is a plus.
• Excellent oral and written communication skills, including presentation and facilitation skills.
• Strong analytical, problem-solving, and critical thinking skills, with an ability to balance attention to detail with a big-picture perspective.
• Strong understanding of regulatory requirements (FDA, 21 CFR Part 211, EU GMP, ICH Q10).

Pay

$58/HR - $65/hr