Senior Deviation Specialist (80%-100%)
lonza · Visp
Description du poste
About the role
Lonza's Quality organization in Visp, Switzerland is looking for a Senior Deviation Specialist for a fully site-based role. You will lead complex investigations, drive continuous improvement and collaborate across functions to keep the highest GMP standards, helping ensure the quality, compliance and reliability of life-saving therapies.
Key responsibilities
- Lead complex GMP deviation investigations using structured root cause analysis methods to find underlying issues and implement sustainable solutions.
- Work closely with Manufacturing, Quality Control, Engineering and other stakeholders to gather data, evaluate findings and drive effective CAPAs.
- Write clear, scientifically sound and compliant deviation reports in line with internal procedures and global regulatory expectations.
- Monitor CAPA implementation and effectiveness, ensuring timely completion and reducing the risk of recurring deviations.
- Act as a subject matter expert during internal and external audits, supporting inspection readiness and defending investigation outcomes.
- Analyze deviation trends, identify improvement opportunities and contribute to initiatives that strengthen process reliability and product quality.
- Take part in risk assessments and change control activities to prevent quality issues and support continuous improvement.
Required profile
- Several years of experience in a GMP-regulated pharmaceutical, biotechnology or medical device environment, focused on quality systems, deviation management, QA or QC.
- Degree in a scientific or engineering discipline, or equivalent experience.
- Strong understanding of cGMP requirements and global regulatory expectations, including FDA, EMA and ICH guidelines.
- Excellent written and verbal communication in German and English.
Required skills
- Root cause analysis methods such as 5 Whys, Fishbone Diagrams, FMEA or similar structured problem-solving approaches.
- Quality management systems such as TrackWise, Veeva or comparable platforms.
- Ability to interpret data, assess risks and make sound quality decisions in a fast-paced manufacturing environment.
What we offer
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits depending on role and location.
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