QA Compliance Lead – Senior Quality Assurance

About the role

Novartis is seeking a senior Quality Assurance Compliance leader to protect and continuously improve the GMP compliance landscape at its Stein site in Switzerland. The role requires deep regulatory expertise, strategic oversight, and the ability to lead complex, regulated environments.

Key responsibilities

• Provide overall leadership and strategic oversight of Quality Compliance activities in line with cGxP requirements.
• Act as the senior quality authority for audits, inspections, and health‑authority interactions, ensuring sustained inspection readiness.
• Own and continuously develop the Quality Management System, including deviations, CAPAs, change control, and data integrity.
• Lead GxP risk management, incident management, and compliance remediation activities.
• Ensure regulatory and quality oversight of site activities, suppliers, and service providers.
• Drive a strong quality culture and serve as a role model for integrity and patient focus.
• Coach and develop senior quality professionals to ensure sustainable expertise.
• Champion Lean Leadership and operational‑excellence initiatives.

Required profile

• Minimum 15 years of progressive QA and compliance experience in a GMP‑regulated pharmaceutical or biotech environment.
• Proven senior QA leadership with accountability for compliance strategy and inspection outcomes.
• University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology or related discipline.
• Fluent English; German is a strong advantage for Switzerland.
• Strong executive presence and credibility when interacting with senior internal and external stakeholders.

Required skills

• cGMP expertise.
• Quality Management System (QMS) implementation and maintenance.
• CAPA and change‑control processes.
• Data integrity assurance.
• GxP risk management.
• Lean Leadership methodology.
• Regulatory frameworks knowledge (EMA, FDA, Swissmedic).