Data integrityEMARegulatory frameworksLean LeadershipcGMPSwissmedicFDAQuality assuranceRisk ManagementQuality management systemCAPA managementGxP compliance
Languages
English C2
German
Description
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.
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
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
Tech stack
Quality Management System (QMS)cGMPQuality Systems
Benefits
Commitment to Diversity and Inclusion
Accessibility and Accommodation
Company
Novartis
Pharmaceuticals
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
