Process Lead - QMS

About the role

The Process Lead – QMS will head the Quality Assurance Compliance team, ensuring that all operations meet cGMP, GDP, ISO and regulatory standards. This senior position drives continuous improvement and maintains a robust Quality Management System across the organization.

Key responsibilities

• Lead daily QA compliance activities and oversee the QMS implementation, maintenance and improvement.
• Supervise deviation, CAPA, change control and risk assessment closure.
• Plan, coordinate and conduct internal audits and prepare for regulatory inspections.
• Manage documentation lifecycle, ensuring SOPs, quality manuals and controlled documents comply with Good Documentation Practices.
• Coach and develop the QA compliance team, delivering GMP and compliance training.
• Lead continuous‑improvement and risk‑management projects, promoting data‑integrity (ALCOA+).
• Follow ISO 14001:2015 EMS and HSE policies, reporting hazards and supporting environmental initiatives.

Required profile

• Bachelor’s or master’s degree in Pharmacy, Chemistry, Biology, Biotechnology or a related field.
• 5‑10 years of experience in Quality Assurance/Compliance within the pharmaceutical or biotech industry.
• Proven ability to lead teams and manage complex audit and inspection programs.

Required skills

• cGMP, GDP and ISO standards knowledge.
• CAPA, deviation and change‑control management.
• Audit planning and execution.
• Document control and Good Documentation Practices.
• Risk assessment and data‑integrity (ALCOA+).
• Environmental Management System (ISO 14001) awareness.

What we offer

• Opportunity to lead a high‑impact QA function in a leading pharmaceutical company.
• Professional development and continuous‑learning environment.
• Collaborative culture focused on quality and compliance excellence.