QA Compliance Specialist 2

About the role

The QA Specialist QA Compliance supports and maintains the site's Quality Management System (QMS) by ensuring alignment between local quality procedures and Lonza Group Quality Standards. The role leads structured gap assessments, identifies compliance gaps, coordinates remediation activities, and ensures timely implementation of required changes. It collaborates with Global Quality, Manufacturing, Quality Operations, Engineering, Regulatory Affairs, and other stakeholders to maintain compliance with corporate standards and applicable GMP regulations while driving continuous improvement.

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.

Requirements

• Bachelor's Degree in Life Sciences; Master's degree or equivalent experience preferred.
• 3-5 years in Quality Assurance.
• Project Management experience.
• Experience with presentation, customer liaison, and meeting facilitation.
• Demonstrates flexibility to adapt to changing business priorities.
• Ability for effective planning, organizing, and controlling.
• Sound decision-making considering broad scope of factors.
• Able to manage multiple priorities and achieve results under tight timelines and pressure.
• Knowledge of continuous improvement within adherence to standardized procedures and cGMP compliance.
• Experience with Trackwise, SAP, or Document Management Systems preferred.

Skills

• Detail-oriented and self-motivated.
• Strong willingness to listen to others.
• Self-starter with solid written and verbal communication.
• Good attention to detail.
• Works effectively individually and with teams.
• Positive attitude and customer-focused.
• Practices safety awareness at all times.