QA Manager Deviations
Lonza
Visp, Switzerland
Join Lonza in Visp as a QA Manager Deviations (m/f/d) and become an integral part of a talented team dedicated to making a global impact in the field of life sciences. This position based in Switzerland is essential in maintaining compliance with regulatory requirements and internal quality standards. You will have the opportunity to contribute directly to the continuous improvement of our world-class quality management system in a collaborative and ambitious environment.
Key responsibilities:
- Review and approve deviation reports to ensure completeness, accuracy, and compliance with regulatory requirements (e.g., FDA, EMA) and internal quality standards.
- Evaluate proposed root cause analyses and CAPA to ensure adequacy in preventing recurrence.
- Collaborate with multi-functional teams (e.g., manufacturing, QC, engineering) to ensure quality issues are addressed and resolved appropriately.
- Supervise deviation trends and quality metrics to identify areas for improvement and report findings to senior management.
- Drive continuous improvement initiatives related to deviation management processes.
- Support internal and external audits, inspections, and regulatory submissions by providing information on deviation management practices.
- Provide mentorship and training to staff on deviation management and related quality topics.
Key requirements:
- Bachelor degree or equivalent experience in Life Sciences, Pharmacy, Biotechnology, or a related field.
- Sufficient experience in Quality Assurance within the pharmaceutical or biotech industry, with a focus on deviation management.
- Strong knowledge of regulatory requirements (e.g., FDA, EMA, ICH) related to quality management.
- Experience with quality management systems (e.g., TrackWise, Veeva) and CAPA processes.
- Excellent attention to detail and problem-solving skills.
- Strong communication and interpersonal skills, with the ability to work collaboratively in a cross-functional environment.
- Proficient English is required and good German language skills – an advantage.
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