Project Manager, Quality Assurance

Responsible for planning, coordinating, and executing Quality Assurance projects to ensure timely delivery, regulatory compliance, and alignment with business objectives. Collaborates with cross-functional teams to manage project timelines, risks, quality systems, CAPA, change controls, and documentation while ensuring compliance with applicable GxP/GMP requirements.

• 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
• 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; escalate 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.