(Senior) QA Expert Compliance 80-100%

Lonza seeks a Senior QA Expert Compliance to lead QMS development, ensure GMP adherence, and drive quality excellence in a sterile manufacturing setting in Stein, Switzerland.

This position focuses on partnering with senior stakeholders to maintain robust Quality Management Systems and ensure GMP compliance across various platforms. The role involves managing change reviews, overseeing training, and driving quality initiatives within a fast-paced sterile manufacturing environment. It is designed for a resilient professional who can work independently and adapt to shifting priorities.

Responsibilities

• Develop, implement, and maintain the Quality Management System in line with cGMP, ISO, and other regulatory standards.
• Serve as a subject matter expert on compliance matters, offering guidance and training to different departments on quality principles and regulatory expectations.
• Oversee the investigation and resolution of deviations, CAPAs, and change controls, including effectiveness checks.
• Review and approve quality documentation, such as standard operating procedures.
• Prepare and present compliance reports and metrics to management, highlighting trends, risks, and mitigation strategies.
• Represent the company during regulatory inspections and customer audits, demonstrating robust compliance practices.
• Collaborate cross-functionally with Manufacturing, QC, MSAT, Engineering, and Supply Chain to embed quality throughout the product lifecycle.
• Monitor evolving global regulations and industry trends, assessing their impact on operations.

Requirements

• MSc in a scientific field (BSc minimum, PhD preferred) with extensive QA experience in a GMP-controlled pharmaceutical manufacturing environment.
• Strong background in QMS with proven experience in managing deviations, CAPAs, change controls, and document management in GMP settings.
• Hands-on experience with document management and quality systems such as TrackWise, MasterControl, DMS, or Cornerstone.
• Experience in sterile manufacturing, pharma production, clinical testing, or similar fields with a focus on compliance and training oversight.
• Analytical, decisive, and resilient professional who communicates complex topics clearly, works independently, and thrives in fast-paced, changing environments.

Nice to have

• Experience with Veeva is highly beneficial.
• PhD preferred.

What the company offers

• An agile career and a dynamic work culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Relocation assistance is available for eligible candidates and their families, if needed.
• In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits.

About the company

Lonza values its people as its greatest strength, fostering a culture built on collaboration, accountability, excellence, passion, and integrity. The company believes that innovation thrives when diverse perspectives are brought together, and is committed to creating an inclusive environment where everyone's ideas can improve millions of lives.

• Core values of Collaboration, Accountability, Excellence, Passion, and Integrity guide how the team works together.
• Innovation is encouraged through diverse perspectives and unique backgrounds.
• The company is committed to diversity and creating an inclusive environment for all employees.
• Everyone's contributions have the potential to improve millions of lives.