QA Project Manager: Cross-Functional, GxP Focus

Cloud Analytics Technologies, LLC; Boston (MA); Presencial; USD 86.000 - 123.000; Tempo integral

Resumo da vaga

Cloud Analytics Technologies, LLC in Boston seeks a Project Manager, Quality Assurance with 5+ years in QA project delivery within regulated environments. You will plan, track, and lead cross-functional teams across QA, Manufacturing, Regulatory Affairs, Clinical Operations, and Supply Chain to ensure on-time delivery and compliance with GxP standards.

You will establish project plans, risk logs, dashboards, and exec updates, while coordinating change controls, CAPAs, and audit readiness

Qualificações

• Bachelor's degree or equiv in life sciences, business, engineering or PM.
• 5+ years leading QA/quality-systems projects in regulated settings.
• Experience with cross-functional, multi-site projects and tight timelines.
• Knowledge of GxP, GMP, GCP, GDP or similar standards.
• Skills in planning, scheduling, risk assessment, reporting.

Responsabilidades

• Lead planning and delivery of QA projects from initiation to completion.
• Create and maintain project plans, milestones, and risk logs.
• Coordinate QA, Manufacturing, Regulatory, Clinical Ops, Supply Chain teams.
• Facilitate meetings, document decisions, owners, and due dates.
• Track scope, timelines, deliverables, risks, and issues; escalate as needed.
• Support QA initiatives: quality systems, audits, process improvements.
• Ensure activities align with GxP requirements and internal procedures.
• Help manage QMS activities: change controls, deviations, CAPAs, docs.
• Prepare concise dashboards and executive updates for stakeholders.
• Assist in corrective actions from findings or audits.
• Identify ways to improve project management practices and collaboration.
• Maintain inspection-ready documentation throughout engagement.

Conhecimentos

Project management

Cross-functional collaboration

Stakeholder communication

Analytical thinking

Problem solving

Facilitation

Decision making

Influence without authority

Formação

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

Ferramentas

Jira

Confluence

Microsoft Project

Smartsheet

Excel

PowerPoint

Word

Outlook

Teams

Veeva Vault

TrackWise

MasterControl

Descrição da vaga

Cloud Analytics Technologies, LLC in Boston seeks a Project Manager, Quality Assurance with 5+ years in QA project delivery within regulated environments. You will plan, track, and lead cross-functional teams across QA, Manufacturing, Regulatory Affairs, Clinical Operations, and Supply Chain to ensure on-time delivery and compliance with GxP standards.

You will establish project plans, risk logs, dashboards, and exec updates, while coordinating change controls, CAPAs, and audit readiness