Quality Assurance, QMS Manager

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit
Switzerland, Basel

Quality Assurance Manager (QMS Specialist)

Location: Basle/Switzerland

Fixed Term Contract – End Date December 2025

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Role Purpose:

Develop and maintain the QMS of Lonza Sales AG

Key responsibilities:

  • Collaborate with cross-functional teams to design, implement, and continuously improve the QMS.
  • Develop and maintain SOPs, work instructions, and quality manuals related to trade, import, and wholesale processes.
  • Conduct internal audits and assessments to identify areas for improvement.
  • Ensure compliance with Swiss and international regulations (e.g., Swissmedic, EU GMP).
  • Provide training to staff on QMS procedures and quality-related topics.
  • Investigate deviations, CAPAs, and non-conformities, implementing corrective actions as needed.
  • Monitor supplier quality and perform risk assessments.
  • Participate in regulatory inspections and support external audits.
  • Ensuring that a quality management system is implemented and maintained
  • Ensure contribution to the implementation of a quality risk management system
  • Ensure Product Review evaluation is performed in the area of responsibility
  • Ensure participation and contribution in the Management Review in the area of responsibility
  • Focusing on the management of authorized activities and the accuracy of and quality of records
  • Ensure inspection readiness for Lonza Sales AG.
  • Supporting the Responsible Person (FvP) of Lonza Sales AG during regulatory inspections.

Key requirements:

  • Master's degree in chemistry, biotechnology, life science or related field.
  • 5 years experience within the pharma industry
  • In depth knowledge of GDP practice requirements and regulations
  • Strong knowledge of QMS Principles, ICH Guidelines
  • GDP Certificates or other relevant certifications are a plus
  • Strong attention to quality
  • Excellent verbal, written and interpersonal communications skills in English (German or French is a plus)
  • Requires independent decision making regarding quality and compliance
  • Professional attitude to sustain excellent working relationships with other sites and regulators

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

#LI-SG1

Reference: R60027Apply Similar JobsR58117R59692R60030R60032R60033 Switzerland, Basel

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