Job Description Summary
Location: Stein, SwitzerlandWe 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.
Job 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.
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 [email protected] 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
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Skills Desired
Communication Skills, LeadershipSkills Required
- Minimum 15 years of progressive experience in Quality Assurance and Compliance
- Proven track record in senior QA leadership roles
- Deep expertise in cGMP, Quality Systems, and regulatory frameworks
- Extensive experience leading health authority inspections
- Strong credibility and executive presence
- Demonstrated ability to lead and influence
- University degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline
- Fluent in English; German is a strong advantage
Novartis Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.
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Healthcare Strength — Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
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Retirement Support — Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
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Parental & Family Support — Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.
Novartis Insights
What We Do
Novartis is an innovative medicines company. Every day, working 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 more than 250 million people worldwide.
