(Senior) QA Expert Compliance 80-100%

Responsibilities

• Lead and participate in the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with cGMP, ISO, and other applicable regulatory requirements.
• Act as a subject matter expert for compliance-related topics, providing guidance and training to various departments on quality principles, regulatory expectations, and best practices.
• Manage and investigate deviations, CAPAs (Corrective and Preventive Actions), and change controls, ensuring timely resolution and effectiveness checks.
• Review and approve quality-related documentation, including but not limited to standard operating procedures (SOPs).
• Prepare and present compliance reports and metrics to management, highlighting trends, risks, and proposed mitigation strategies.
• Represent the company during regulatory inspections and customer audits, responding to inquiries and demonstrating robust compliance practices.

Requirements

• Education & experience: MSc (minimum BSc, PhD preferred) in a scientific field with extensive experience in a QA function within the GMP controlled, pharmaceutical manufacturing environment is a must
• Quality expertise: Strong QMS background with proven experience in deviations, CAPA, change control, and document management within GMP environments
• Systems know-how: Hands-on experience with document management and quality systems (e.g., TrackWise, MasterControl, DMS, Cornerstone); Experience with Veeva is highly beneficial
• Operational exposure: Experience in sterile manufacturing, pharma production, clinical testing, or similar with focus on compliance and training oversight
• Mindset & skills: Analytical, decisive, and resilient professional who communicates complex topics clearly, works independently, and thrives in fast-paced, changing environments
• About Lonza
• Ready to shape the future of life sciences?

Additional Information

The actual location of this job is in Stein, AG, Switzerland . Relocation assistance is available for eligible candidates and their families, if needed. Join Lonza AG as a (Senior) QA Expert Compliance, partnering with senior stakeholders to ensure robust Quality Management Systems, GMP compliance, and training oversight across various systems and document management platforms. This highly dynamic, transformation-driven role includes change review board responsibilities and cross-functional interface management, ideal for a resilient, curious professional who thrives on shifting priorities, works independently, and drives quality excellence in a fast-growing sterile manufacturing environment. Check out Your Career in Drug Product Services at Lonza ! This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards. What you will get: An agile career and a dynamic work culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits

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