Project Manager, Quality Assurance

Cloud Analytics Technologies, LLC; Boston (MA); On-site; USD 86,000 - 123,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Project management

Cross-functional collaboration

Stakeholder communication

Analytical thinking

Problem solving

Facilitation

Decision making

Influence without authority

Education

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

Tools

Jira

Confluence

Microsoft Project

Smartsheet

Excel

PowerPoint

Word

Outlook

Teams

Veeva Vault

TrackWise

MasterControl

Job description

US Citizen, Green Card, H-1B, OPT-EAD, CPT, Other

Job Title: Project Manager, Quality Assurance

Location: Boston, MA

Duration: 8 Months + Extension

Bill Rate: $76/hour (C2C)

Job Type: W-2, 1099, C2C

Client: To Be Discussed Later

Work Authorization: US Citizen, Green Card, OPT-EAD, CPT, H-4-EAD, Other

Job Description

Key Responsibilities

• Lead the planning and delivery of assigned QA projects from initiation through completion.
• Develop and maintain project plans, timelines, milestones, action trackers, risk logs, and status reports.
• Coordinate cross-functional project teams, including Quality Assurance, Manufacturing, Regulatory Affairs, Clinical Operations, Supply Chain, and other business partners as needed.
• Facilitate project meetings; document decisions, action items, owners, and due dates; and drive timely follow-up.
• Track project scope, timelines, deliverables, dependencies, risks, and issues; escalte concerns and recommend mitigation strategies.
• Support QA initiatives involving quality systems, compliance, audit readiness, process improvement, and operational effectiveness.
• Partner with QA subject matter experts to ensure project activities and deliverables align with internal procedures and applicable GxP requirements.
• Support the coordination of Quality Management System (QMS) activities, which may include change controls, deviations, corrective and preventive actions (CAPAs), document management, and audit-related actions.
• Prepare concise project dashboards, meeting materials, executive updates, and communications for key stakeholders.
• Assist in the development, implementation, and tracking of corrective action plans resulting from project findings, audits, or process assessments.
• Identify opportunities to improve project-management practices, workflows, reporting, and cross-functional collaboration.
• Maintain accurate, complete, and inspection-ready project documentation throughout the engagement.

Required Qualifications & Technical Skills

• Bachelor’s degree in life sciences, business, engineering, project management, or a related discipline.
• 5+ years of project-management experience, including experience supporting Quality Assurance, Quality Systems, Manufacturing Quality, Compliance, or a related function.
• Demonstrated success managing multiple complex, cross-functional projects with competing priorities and aggressive timelines.
• Working knowledge of GxP principles and quality/compliance requirements, including GMP, GCP, GDP, or related standards.
• Experience preparing project plans, schedules, risk assessments, stakeholder communications, and status reporting.
• Strong organizational, analytical, problem-solving, facilitation, and decision-making skills.
• Excellent written and verbal communication skills, including the ability to communicate effectively with technical and non-technical stakeholders.
• Ability to influence cross-functional teams and drive accountability without direct reporting authority.
• Project planning, scheduling, scope management, and milestone tracking
• Ability to identify, track, and communicate project risks, issues, dependencies, and escalation points across complex programs.
• Microsoft Office Suite, including Excel, PowerPoint, Word, Outlook, and Teams
• Project-management and collaboration tools, such as Microsoft Project, Smartsheet, Jira, Confluence, or similar systems
• Electronic Quality Management System (eQMS) and document-management platforms, such as Veeva Vault, TrackWise, MasterControl, or equivalent tools

We are an equal opportunity employer. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, national origin, citizenship/ immigration status, veteran status, or any other status protected under federal, state, or local law.

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