Change Control Project Manager

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

Job Description

The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy T1D team.

The Change Control Project Manager is responsible for supporting the cross-functional project teams executing change controls. The Project Manager will track and report project scope/timeline/milestone status associated with cell and gene therapy T1D team.

Must be detail-driven and have a proven history in managing and driving project success within the biotech industry. The individual requires a strong technical background, solid working knowledge of GMPs, understanding of the drug development pathway through commercialization, and willingness to pivot as priorities change. Knowledge and/or experience with cell / gene therapy methodologies and a strong understanding of risk management will be an asset. Must have excellent communication skills, written and verbal, high attention to detail, and the ability to work effectively in cross-functional, matrixed teams.

Roles And 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.
• 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

Education And Experience

• 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)
• Understanding of risk assessment.