Senior QA Compliance Lead - GMP, Audits & Strategy

Jobs for Humanity; Stein; Vor Ort; CHF 180.000 - 240.000; Vollzeit

Zusammenfassung

Novartis in Stein, Switzerland is seeking a highly senior Quality Assurance Compliance leader to safeguard and strengthen our GMP compliance landscape. This role requires deep regulatory credibility, strategic oversight, and confident leadership in a regulated environment.

The role involves overseeing the QMS, audits, health authority interactions, and collaboration with Manufacturing, Regulatory, and Global Quality. Fluency in English is required; German is advantageous for Switzerland.

Qualifikationen

• 15+ years of QA and compliance experience in GMP environments.
• Senior QA leadership with accountability for strategy and inspection outcomes.
• Fluent in English; German is advantageous for Switzerland.

Aufgaben

• Provide leadership and strategic oversight of Quality Compliance across the site 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 (QMS), including deviations, CAPAs, change control, and data integrity.
• Lead and govern GxP risk management, incident management, and compliance remediation activities.
• Ensure effective regulatory and quality oversight of site activities, suppliers, and service providers.
• Drive a strong quality culture, serving as a role model for integrity, accountability, and patient focus.
• Partner closely with senior stakeholders across Manufacturing, Technical Operations, Regulatory, and Global Quality.
• Coach and develop senior quality professionals, ensuring sustainable expertise and succession within the organization.
• Champion Lean Leadership and operational excellence initiatives.

Kenntnisse

Quality leadership

Regulatory expertise

cGMP knowledge

Audits & inspections

Executive communication

Ausbildung

Life sciences degree

Jobbeschreibung

Novartis in Stein, Switzerland is seeking a highly senior Quality Assurance Compliance leader to safeguard and strengthen our GMP compliance landscape. This role requires deep regulatory credibility, strategic oversight, and confident leadership in a regulated environment.

The role involves overseeing the QMS, audits, health authority interactions, and collaboration with Manufacturing, Regulatory, and Global Quality. Fluency in English is required; German is advantageous for Switzerland.