QA Compliance Specialist II: Quality System Leader

Katalyst CRO; Portsmouth (NH); On-site; USD 90,000 - 110,000; Full time

Job summary

Katalyst CRO in Portsmouth, NH seeks a QA Specialist QA Compliance to support the site's QMS and ensure alignment with Lonza Group Quality Standards. You lead gap assessments, coordinate remediation, and drive timely changes in procedures while collaborating with Global Quality, Manufacturing, Regulatory Affairs, and others.

The role emphasizes continuous improvement, cGMP compliance, and effective documentation, training, and KPI reporting to sustain high quality across processes.

Qualifications

• 3-5 years in Quality assurance.
• Demonstrates flexibility to adapt to changing business priorities.
• Demonstrate ability for effective Planning, Organizing and Controlling competency.
• Demonstrate sound decision making, considering broad scope of factors.

Responsibilities

• Lead gap assessments of local Quality Management System procedures against Group Quality Procedures and Corporate Standards.
• Coordinate updates to local SOPs, work instructions, and controlled documents.
• Track implementation and drive completion to defined timelines.
• Partner with process owners and SMEs to establish and implement compliant solutions.
• Support Change Control, CAPA, Deviations, and Quality Risk Management activities.
• Support internal audits and regulatory inspections.
• Monitor compliance metrics and prepare management reports through trending and visual KPI management.
• Develop and Provide training and guidance on new or revised quality procedures.
• Drive continuous improvement and harmonization of Quality System processes.

Skills

Quality assurance

Project management

Stakeholder liaison

Planning & organizing

Decision making

Multitasking

Communication

Attention to detail

Safety awareness

Self-motivated

Teamwork

Education

Bachelor Degree (Life sciences)

Master's degree or equivalent experience (preferred)

Tools

Trackwise

SAP

Document management system

Job description

Katalyst CRO in Portsmouth, NH seeks a QA Specialist QA Compliance to support the site's QMS and ensure alignment with Lonza Group Quality Standards. You lead gap assessments, coordinate remediation, and drive timely changes in procedures while collaborating with Global Quality, Manufacturing, Regulatory Affairs, and others.

The role emphasizes continuous improvement, cGMP compliance, and effective documentation, training, and KPI reporting to sustain high quality across processes.