Project Manager, Quality Assurance

Ethereum Technologies; Boston (MA); Sur place; USD 86 000 - 123 000; Plein temps

Résumé du poste

Ethereum Technologies in Boston, MA is seeking a Project Manager for Quality Assurance to lead the planning and delivery of QA projects, ensure adherence to GxP and quality systems, and drive timely, compliant outcomes in a fast-paced environment.

You will build project plans, track milestones, coordinate cross-functional teams, prepare dashboards for stakeholders, and support CAPAs, change controls, and audit readiness to maintain inspection-ready documentation.

Qualifications

• Bachelor’s degree in life sciences, business, engineering, project management, or a related discipline.
• 5+ years of project-management experience with QA/QMS/Manufacturing quality.
• Experience with GxP principles (GMP, GCP, GDP) and related standards.
• Experience planning projects, schedules, risk assessments, and status reporting.

Responsabilités

• Lead the planning and delivery of 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 QA, Manufacturing, Regulatory, Clinical Operations, and Supply Chain.
• Facilitate project meetings; document decisions and action items with owners and due dates.
• Track scope, timelines, deliverables, dependencies, risks, and issues; mitigate as needed.
• Support QA initiatives involving quality systems, compliance, audit readiness, and process improvement.
• Partner with QA SMEs to ensure activities align with procedures and GxP requirements.
• Coordinate Quality Management System activities including change controls, deviations, CAPAs, and audit-related actions.
• Prepare concise project dashboards, meeting materials, and executive updates for stakeholders.
• Assist in developing and tracking corrective actions from findings, audits, or process assessments.
• Identify opportunities to improve project-management practices, workflows, and cross-functional collaboration.
• Maintain accurate, inspection-ready project documentation.

Connaissances

Cross-functional collaboration

Stakeholder communication

Risk management

Project planning

Excel/PowerPoint

Jira/Confluence

eQMS awareness

Formation

Bachelor’s degree in life sciences or related field

Outils

Microsoft Project

Smartsheet

Jira

Confluence

Veeva Vault

TrackWise

MasterControl

Description du poste

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-1B, H4-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; escape 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.