Location: Stein, Switzerland
Key Responsibilities
* Provide overall leadership and strategic oversight of Quality Compliance activities 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.
Essential Requirements
* Minimum 15 years of progressive experience in Quality Assurance and Compliance within a GMP‑regulated pharmaceutical or biotech environment.
* Proven track record in senior QA leadership roles, with clear accountability for compliance strategy and inspection outcomes.
* Deep expertise in cGMP, Quality Systems, and regulatory frameworks (EMA, FDA, Swissmedic).
* Extensive experience leading health authority inspections, audits, and complex remediation programs.
* Strong credibility and executive presence when interacting with senior internal and external stakeholders.
* Demonstrated ability to lead, influence, and challenge at senior management level.
* University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline.
* Fluent in English; German is a strong advantage for Switzerland.
Benefits and Rewards
Commitment to Diversity and Inclusion / EEO paragraph.
Accessibility and Accommodation: Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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