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
What you will do:
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.
Collaborate cross‑functionally with Manufacturing, QC, MSAT, Engineering, Supply Chain and other departments to embed quality into all stages of the product lifecycle. Stay abreast of evolving global regulations and industry trends related to quality and compliance, proactively assessing their impact on Lonza's operations.
What we are looking for:
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.
Ready to shape the future of life sciences? Apply now.
#J-18808-Ljbffr
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
What you will do:
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.
Collaborate cross‑functionally with Manufacturing, QC, MSAT, Engineering, Supply Chain and other departments to embed quality into all stages of the product lifecycle. Stay abreast of evolving global regulations and industry trends related to quality and compliance, proactively assessing their impact on Lonza's operations.
What we are looking for:
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.
Ready to shape the future of life sciences? Apply now.
#J-18808-Ljbffr
