Process Lead – Quality Management System (QMS)

About the role

The Process Lead – Quality Management System (QMS) will head the QA Compliance team, ensuring all operations meet cGMP, GDP, ISO and other regulatory standards. This role drives continuous improvement, audit readiness and a strong quality culture across the organization.

Key responsibilities

• Lead daily QA compliance activities and oversee the Quality Management System implementation and improvement.
• Supervise review, closure and trending of deviations, CAPAs, change controls and risk assessments.
• Plan, coordinate and lead internal audits and prepare for regulatory and customer inspections.
• Manage documentation control, SOP approvals and ensure adherence to Good Documentation Practices.
• Coach, train and develop the QA Compliance team, delivering GMP and compliance training.
• Lead continuous‑improvement and risk‑management projects, applying data‑integrity principles (ALCOA+).
• Support Environmental Management System (ISO 14001) and HSE activities, including waste disposal and hazard reporting.

Required profile

• Proven experience leading QA compliance or quality assurance functions in a regulated environment.
• Strong knowledge of cGMP, GDP, ISO standards and regulatory inspection processes.
• Ability to manage audits, CAPA processes and documentation lifecycle.
• Excellent leadership, coaching and training skills.

Required skills

• cGMP
• GDP
• ISO 9001 / ISO 14001
• ALCOA+ data integrity
• CAPA management
• Audit planning and execution
• Quality Management System (QMS) oversight