Project Manager

Ethereum Technologies; Boston (MA); Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Ethereum Technologies seeks a highly organized QA Project Manager to lead cross-functional projects in a regulated life sciences setting. You will drive plans, risk assessments, and status updates from initiation to completion, ensuring GMP/GCP alignment.

You will partner with QA, Manufacturing, Regulatory Affairs, and Clinical Operations to deliver compliant, timely solutions and drive QMS-related improvements. A proven track record in GxP and project leadership is essential.

Qualifications

• 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.

Responsabilités

• Lead 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 Affairs, Clinical Operations, and Supply Chain.
• 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; expedite concerns and 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 align with internal procedures and GxP requirements.
• Support QMS activities, including change controls, deviations, CAPAs, document management, and audit-related actions.
• Prepare concise project dashboards, meeting materials, executive updates, and communications for key stakeholders.
• Assist in developing 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.

Connaissances

Project management

GxP knowledge

Cross-functional leadership

Quality Assurance

Regulatory compliance

MS Office

Jira/Confluence

Documentation

Stakeholder communication

Formation

Bachelor’s degree (life sciences/related)

Outils

Microsoft Project

Smartsheet

Jira

Confluence

Veeva Vault

TrackWise

MasterControl

Description du poste

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

Work Authorization: USC, GC, H-1B, OPT-EAD, GC-EAD, H4-EAD

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; expedite 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.