QA Compliance Lead (m/f/d)

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

Job Description

Summary Location: Stein, Switzerland

We are seeking a highly senior Quality Assurance Compliance leader to safeguard and continuously strengthen our GMP compliance landscape in Switzerland. This role is designed for an experienced quality authority who brings deep regulatory credibility, strategic oversight, and confident leadership in complex, regulated environments.

About the Role

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

Accessibility and Accommodation

Applicable 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 send an e-mail to [emailprotected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Commitment to Diversity and Inclusion / EEO paragraph

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.