Head of Quality Management System & Digital

About the role

The Head of Quality Management System & Digital will define and execute ArCera’s quality strategy across all regions, ensuring compliance with GxP standards throughout the product lifecycle. This senior leader will guide a team of quality professionals, collaborate with cross‑functional partners, and drive continuous improvement through digitalisation and lean initiatives.

Key responsibilities

• Develop and implement a global QMS strategy, policies and standards aligned with GMP, GDP, GCP and GDocP.
• Lead cross‑functional collaboration with Manufacturing, Commercial, Regulatory Affairs and Supply Chain to embed quality into product lifecycle management.
• Oversee day‑to‑day QMS processes, ensuring data integrity and regulatory compliance.
• Design and deliver GxP training programmes to maintain staff proficiency.
• Monitor regulatory trends, build relationships with authorities and position ArCera as a quality leader.
• Implement lean processes, eliminate redundancies and drive automation and digitalisation of quality activities.

Required profile

• Proven senior leadership experience in quality management within the life‑sciences or pharmaceutical sector.
• Deep knowledge of GxP regulations (GMP, GDP, GCP, GDocP) and their application across product lifecycles.
• Track record of leading continuous‑improvement and digital transformation projects.
• Strong stakeholder management skills and ability to influence across multiple regions.

Required skills

• GMP, GDP, GCP, GDocP regulatory expertise
• Lean methodology
• Digitalisation and automation concepts for quality processes