QA Compliance Lead (m/f/d)

Myjob; Schaffhausen; Vor Ort; CHF 210.000 - 260.000; Vollzeit

Zusammenfassung

Novartis is seeking a highly senior Quality Assurance Compliance leader to safeguard and strengthen the GMP compliance landscape in Switzerland. Location: Stein, Switzerland.

The role requires deep regulatory credibility, strategic oversight, and confident leadership in a complex, regulated environment. The candidate will lead QA activities, own the QMS, drive risk management, and oversee audits and health authority interactions, partnering with senior stakeholders across Manufacturing,

Qualifikationen

• 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 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 remediation programs.
• Strong executive presence when interacting with senior stakeholders.
• Demonstrated ability to lead, influence, and challenge at senior management level.
• University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline.
• Fluent in English; German is a strong advantage for Switzerland.

Aufgaben

• 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.

Kenntnisse

Executive leadership

QA leadership

Regulatory compliance

GxP risk management

Audits & inspections

QMS ownership

Deviations & CAPAs

Data integrity

Stakeholder management

Lean leadership

Ausbildung

University degree in Life Sciences/Pharmacy/Chemistry/Biotechnology

Jobbeschreibung

Company Description

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach 296 million people worldwide. We want to create an inclusive workplace where every one of us can be our best and true selves, so that together we can discover more, reach underserved communities and reimagine medicine.

Company Name: Novartis

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

Benefits & Rewards

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.

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 E-Mail schreiben and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally.

https://www.novartis.com/careers/benefits-rewards

Quality Operations Switzerland

Job ID

REQ-10074385

QA Compliance Lead (m/f/d)

Qualifications

Additional Information