Project Manager, Quality Assurance

MACHINE LEARNING TECHNOLOGIES LLC; Boston (MA); Presencial; USD 96.000 - 124.000; Tempo integral

Resumo da vaga

MACHINE LEARNING TECHNOLOGIES LLC is seeking a Project Manager, Quality Assurance in Boston to lead QA projects from initiation to completion. The role coordinates cross-functional teams across QA, manufacturing, regulatory affairs, and supply chain, while maintaining detailed plans, risk logs, and dashboards.

The ideal candidate brings 5+ years in project management within QA or quality systems, strong communication skills, and a proven ability to influence diverse teams without direct

Qualificações

• Bachelor’s degree in life sciences, business, engineering, or a related discipline.
• 5+ years of project-management experience supporting QA, quality systems, manufacturing quality, compliance, or related functions.
• 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 for 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.

Responsabilidades

• 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 QA, Manufacturing, Regulatory Affairs, Clinical Operations, Supply Chain, and others.
• Facilitate project meetings; document decisions, action items, owners, and due dates; drive timely follow-up.
• Track project scope, timelines, deliverables, dependencies, risks, and issues; elevate concerns and mitigate.
• Support QA initiatives involving quality systems, compliance, audit readiness, process improvement, and operational effectiveness.
• Partner with QA SMEs to ensure activities and deliverables align with GxP requirements.
• Coordinate QMS activities, including change controls, deviations, CAPAs, documents, and audit actions.
• Prepare concise project dashboards, meeting materials, executive updates, and stakeholder communications.
• Assist in developing and tracking corrective action plans from audits or process assessments.
• Identify opportunities to improve project-management practices and cross-functional collaboration.
• Maintain accurate, complete, inspection-ready project documentation.

Conhecimentos

GxP knowledge

Cross-functional leadership

Project management

Stakeholder communications

Risk management

Office tools

Process improvement

Formação

Bachelor’s degree in life sciences, business, engineering, or related

Ferramentas

Microsoft Project

Smartsheet

Jira

Confluence

Veeva Vault

TrackWise

MasterControl

Excel

Descrição da vaga

Job Description

Job Overview

• Job ID: J53911
• Job Title: Project Manager, Quality Assurance
• Location: Boston, MA
• Duration: 24 Months + Extension
• Domain Exposure: Banking & Finance
• Client: To Be Discussed Later
• Employment Type: W-2, 1099, C2C
• Work Authorization: US Citizen, Green Card, H-1B, OPT-EAD, CPT, Other
• 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
• Duration: 8 Months + Extension

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; elevate 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

Equal Opportunity Employer

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.