Senior Deviation Specialist 80%-100% (m/w/d)

Lonza Group

Oberwallis

Remote

CHF 110,000 - 150,000

Full time

24 hours ago
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Benefits offered by this job

Agile career culture
Inclusive workplace
Compensation programs
Role-based benefits

Job summary

Lonza in Visp, Switzerland, is seeking a Senior Deviation Specialist for a fully site-based role. You will lead complex GMP deviation investigations, drive CAPAs, and partner with Manufacturing, Quality, and Engineering to ensure product quality and regulatory compliance.

You will author clear deviation reports, monitor CAPA effectiveness, and participate in audits and risk assessments. The position requires strong German and English communication and deep cGMP knowledge.

Qualifications

  • Experience in GMP-regulated pharma/biotech/medical device quality systems.
  • Strong root cause analysis methods such as 5 Whys / Fishbone.
  • Ability to interpret data, assess risks, and make quality decisions.
  • In-depth knowledge of cGMP and global regulatory expectations.
  • Excellent written and spoken German and English.
  • Experience with TrackWise, Veeva or similar QMS.
  • Degree in a scientific or engineering discipline.

Responsibilities

  • Lead GMP deviation investigations and implement sustainable CAPAs.
  • Collaborate with Manufacturing, Quality, and Engineering teams.
  • Author compliant deviation reports and support audits.
  • Analyze deviation trends and drive process improvements.
  • Monitor CAPA effectiveness and participate in risk assessments.

Skills

Root cause analysis
Data interpretation
GMP knowledge
German & English
QMS TrackWise/Veeva
Cross-functional collab

Education

Degree in science/engineering

Tools

TrackWise
Veeva

Job description

Senior Deviation Specialist 80%-100% (m/w/d)

Senior Deviation Specialist

The actual location of this job is in Visp, Switzerland.

Join Lonza's Quality organization in Visp and play a critical role in ensuring the quality, compliance, and reliability of life-saving therapies. As a Senior Deviation Specialist, you will lead complex investigations, drive continuous improvement initiatives, and collaborate across functions to maintain the highest GMP standards.

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 dynamic working culture.
  • An inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • A variety of benefits dependent on role and location.
  • Lead complex GMP deviation investigations, utilizing structured root cause analysis methodologies to identify underlying issues and implement sustainable solutions.
  • Partner closely with Manufacturing, Quality Control, Engineering, and other cross-functional stakeholders to gather data, evaluate findings, and drive effective CAPAs.
  • Author clear, scientifically sound, and compliant deviation reports in accordance 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.
  • Participate in risk assessments and change control activities to proactively prevent quality issues and support continuous improvement.
What we are looking for
  • Experience working within a GMP-regulated pharmaceutical, biotechnology, or medical device environment, including several years focused on quality systems, deviation management, quality assurance, or quality control.
  • Strong expertise in root cause analysis methodologies such as 5 Whys, Fishbone Diagrams, FMEA, or similar structured problem-solving approaches.
  • Ability to interpret data, assess risks, and make sound quality decisions in a fast-paced manufacturing environment.
  • Strong understanding of cGMP requirements and global regulatory expectations, including FDA, EMA, and ICH guidelines.
  • Excellent written and verbal communication skills in German and English, with the ability to communicate complex technical information clearly.
  • Experience working with quality management systems such as TrackWise, Veeva, or comparable platforms.
  • Degree in a scientific or engineering discipline, or equivalent experience that provides a strong foundation in quality and compliance principles.
About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

  • Take ownership, step forward, and enjoy meaningful responsibility
  • Love solving problems and thrive in a complex, fast-moving environment
  • Are curious, always looking to learn and improve
  • Work collaboratively, contributing to something bigger than yourself
  • Are motivated to make a difference through work that impacts customers and their patients
Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.

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