On-Site GxP Quality Project Lead

Vertex Pharmaceuticals LLC; Boston (MA); Vor Ort; USD 110.000 - 124.000; Vollzeit

Zusammenfassung

Vertex Pharmaceuticals LLC is seeking a Contract Project Manager to support planning, coordination, execution, and delivery of priority quality initiatives on an on-site basis in the United States. You will partner with QA and cross-functional teams to drive project activities across quality systems, compliance, and operational excellence.

The role requires 5+ years of project-management experience in regulated environments, with strong organizational and communication skills to manage multiple

Qualifikationen

• 5+ years of project-management experience in QA or related function.
• GxP principles knowledge (GMP, GCP, GDP) and compliance requirements.
• Experience drafting project plans, schedules, and risk assessments.
• Experience managing cross-functional projects with aggressive timelines.
• Excellent communication with technical and non-technical stakeholders.
• Ability to influence teams without direct reporting authority.

Aufgaben

• Lead planning and delivery of QA projects from initiation to completion.
• Develop and maintain project plans, timelines, milestones, risk logs, and dashboards.
• Coordinate cross-functional teams including QA, Manufacturing, Regulatory, Clinical Ops, and Supply Chain.
• Facilitate meetings; document decisions and owners with due dates and follow-up.
• Track scope, timelines, deliverables, risks, issues, and escalation points.
• Support QA initiatives involving quality systems, compliance, and process improvements.
• Partner with QA SMEs to ensure alignment with GxP requirements.
• Coordinate QMS activities such as change controls, deviations, CAPAs, and document management.
• Prepare concise project dashboards and executive updates for stakeholders.
• Assist in corrective action plans and cross-functional process improvements.

Kenntnisse

Project management

GxP compliance

Cross-functional leadership

Risk management

Communication skills

MS Office

Jira/Confluence

Ausbildung

Bachelor's degree in life sciences, business, engineering, project management, or related discipline

Tools

Jira

Confluence

Smartsheet

Microsoft Project

Veeva Vault

TrackWise

MasterControl

Jobbeschreibung

Vertex Pharmaceuticals LLC is seeking a Contract Project Manager to support planning, coordination, execution, and delivery of priority quality initiatives on an on-site basis in the United States. You will partner with QA and cross-functional teams to drive project activities across quality systems, compliance, and operational excellence.

The role requires 5+ years of project-management experience in regulated environments, with strong organizational and communication skills to manage multiple