Project Manager, Quality Assurance

Katalyst-Healthcares-; Boston (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

Katalyst-Healthcares- seeks a seasoned QA Project Manager to lead planning and delivery of cross-functional QA initiatives. You will coordinate with QA, manufacturing, regulatory, and clinical operations to ensure timely, compliant project execution.

The role requires a Bachelor's in a life sciences or related field, 5+ years of project-management experience in QA or quality systems, and strong skills in GxP, risk management, and stakeholder communication. This position is on-site in Boston, MA.

Qualifications

• Bachelor's degree in life sciences, business, engineering, project management, or a related discipline.
• 5+ years of project-management experience supporting QA, quality systems, or related functions.
• Demonstrated success managing multiple complex cross-functional projects with aggressive timelines.
• Working knowledge of GxP principles and quality/compliance requirements (GMP, GCP, GDP).
• 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 with both technical and non-technical stakeholders.
• Ability to influence cross-functional teams and drive accountability without direct authority.
• Project planning, scheduling, scope management, and milestone tracking.
• Ability to identify, track, and communicate risks, issues, dependencies, and escalation points.

Responsibilities

• 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 teams including QA, Manufacturing, Regulatory, Clinical Ops, and Supply Chain.
• Facilitate project meetings; document decisions and follow-up items.
• Track scope, timelines, deliverables, risks, and issues; escalate concerns and suggest mitigations.
• Support QA initiatives involving quality systems, audit readiness, and process improvement.
• Partner with QA SMEs to ensure alignment with procedures and GxP requirements.
• Coordinate QMS activities including change controls, deviations, CAPAs, documents, and audits.
• Prepare concise dashboards, meeting materials, and executive updates for stakeholders.
• Assist in corrective action plan development and tracking from audits or findings.
• Identify opportunities to improve project-management practices and cross-functional collaboration.
• Maintain inspection-ready project documentation throughout engagement.

Skills

Project management

Cross-functional leadership

GxP knowledge

Regulatory compliance

Stakeholder communication

Risk management

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Project

Smartsheet

Jira

Confluence

Veeva Vault

TrackWise

MasterControl

Office 365

Job description

Roles and 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; escalag 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.

Education and Experience:

• 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
• Project reporting, dashboard development, and presentation preparation