QA Project Leader: Delivery & Quality Systems

Katalyst-Healthcares-; Boston (MA); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Project management

Cross-functional leadership

GxP knowledge

Regulatory compliance

Stakeholder communication

Risk management

Ausbildung

Bachelor's degree in life sciences or related field

Tools

Microsoft Project

Smartsheet

Jira

Confluence

Veeva Vault

TrackWise

MasterControl

Office 365

Jobbeschreibung

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.