Project Manager, Inspection Readiness & Commercial Readiness Operations (Contract)

Job Description

Job Title: Project Manager, Inspection Readiness & Commercial Readiness Operations (Contractor)

 

Location: Hybrid / On-site

 

Work Model: On-site 3–4 days per week, aligned with Vertex ways of working

 

Department: Cell and Gene Therapy – Project Management and Strategic Operations

 

Company Overview

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. Our teams work across research, development, manufacturing, and commercialization to advance high-impact therapies for patients. At Vertex, we are committed to scientific excellence, collaboration, and delivering meaningful outcomes with urgency and integrity.

 

Role Summary

The Project Management and Strategic Operations team within Cell and Gene Therapy at Vertex is seeking a Project Manager contractor with prior experience inspection readiness and commercial readiness to lead initiatives that support regulatory inspection readiness and commercial manufacturing preparedness. This role will partner across Quality, Regulatory, Manufacturing, QC, Supply Chain, and other key functions to ensure the organization is prepared for health authority inspections and commercial execution milestones. The successful candidate will bring strong capabilities in project management, stakeholder management, and operational execution, with the ability to quickly learn and apply new information in a dynamic environment. This individual will be solution-oriented and able to leverage knowledge of cGMP manufacturing and cross-functional program execution to manage complex workstreams that support key Vertex goals.

 

The ideal candidate is highly collaborative, organized, and comfortable managing timelines, risks, dependencies, and partner relationships across internal and external teams.

 

Key Responsibilities

• Lead cross-functional project plans for inspection readiness and commercial readiness initiatives.
• Develop and maintain integrated timelines, milestones, risk logs, and status reporting for readiness activities.
• Coordinate stakeholders across Quality, Regulatory Affairs, Manufacturing, Supply Chain, Commercial, and other business functions.
• Drive planning and execution of activities related to regulatory inspections, audits, mock inspections, and readiness assessments.
• Support inspection preparation by tracking deliverables, coordinating documentation readiness, and facilitating issue resolution.
• Partner with functional leaders to identify gaps, risks, and dependencies that may impact inspection or commercial launch readiness.
• Establish governance routines, including project team meetings, steering committee updates, and executive communications.
• Monitor readiness metrics and provide clear, timely updates on project health, risks, mitigations, and critical decisions.
• Ensure alignment between operational readiness plans and commercial launch objectives.
• Facilitate cross-functional decision-making and help resolve issues that may delay key milestones.
• Ensure activities are executed in compliance with applicable GxP, quality, and regulatory requirements.

Required Qualifications & Technical Skills

• Bachelor’s degree in Life Sciences, Engineering, Business, Project Management, or a related field.
• 5 - 8 years of experience in project management within biotechnology, pharmaceuticals, cell and gene therapy, or another regulated environment.
• Demonstrated ability to develop and manage project timelines, milestones, risk registers, dashboards, and action trackers.
• Proficiency with Microsoft Project, Smartsheet, and Microsoft Office Suite, including PowerPoint, Excel, Word, and Outlook.
• Experience in cross-functional team management, including meeting coordination, agendas, minutes, action tracking, and follow-up.
• Ability to identify, track, and communicate project risks, issues, dependencies, and escalation points across complex programs.
• Experience supporting or coordinating inspection readiness and/or commercial readiness activities in a regulated environment.
• Strong communication skills, including the ability to clearly articulate project status, dependencies, and risks to cross-functional teams and leadership.
• Highly collaborative, with proven ability to partner effectively across MFG, QA/QC, Regulatory CMC, and other stakeholder groups.
• Strong organizational skills, attention to detail, and ability to learn quickly and apply feedback effectively.
• Ability to work on-site 3–4 days per week to support project team meetings and cross-functional collaboration.

Preferred Skills

• Experience supporting regulatory inspection readiness activities in a GMP environment.
• Familiarity with commercial launch readiness or late-stage operational readiness planning.
• Experience creating leadership-ready slide presentations and project updates.
• Ability to influence without direct authority in a matrixed organization.
• Experience in Cell and Gene Therapy development and manufacturing environments.

 

Pay Range

$80-$85/HR

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

 

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