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Lonza

Global life sciences contract manufacturer

Senior Deviation Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeVisp, SwitzerlandNo salary listed

About the Job

Requirements

  • Experience in a GMP-regulated pharmaceutical, biotechnology, or medical device environment, including several years focused on quality systems, deviation management, quality assurance, or quality control.
  • Expertise in structured root cause analysis methodologies such as 5 Whys, Fishbone Diagrams, or Failure Mode and Effects Analysis (FMEA).
  • Ability to interpret data, assess risks, and make sound quality decisions in a fast-paced manufacturing environment.
  • Understanding of current Good Manufacturing Practice (cGMP) requirements and global regulatory expectations, including FDA, EMA, and ICH guidelines.
  • Written and verbal communication skills in German and English, including the ability to communicate complex technical information clearly.
  • Experience with quality management systems such as TrackWise, Veeva, or comparable platforms.
  • A degree in a scientific or engineering discipline, or equivalent experience providing a strong foundation in quality and compliance principles.

Responsibilities

  • Lead complex GMP deviation investigations using structured root cause analysis methodologies to identify underlying issues and implement sustainable solutions.
  • Partner with Manufacturing, Quality Control, Engineering, and other cross-functional stakeholders to gather data, evaluate findings, and drive effective corrective and preventive actions (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.

About the Company

Lonza

Global life sciences contract manufacturer

Lonza is a global provider of development and manufacturing services for the pharmaceutical, biotechnology, and nutrition sectors. It supports clients from early development through to commercial production, offering integrated processes such as process development, GMP manufacturing, formulation, fill-finish, and quality assurance to bring medicines and nutrition products to market. Lonza’s model is built on end-to-end CDMO capabilities, enabling companies to move from concept to scalable, compliant production with reliable supply chains. What sets Lonza apart is its long history and global footprint, combining decades of experience across chemistry, biology, and nutrition with a broad, end-to-end service network that supports projects from discovery to commercialization. The company aims to be a trusted, long-term partner in life sciences by helping customers efficiently develop and manufacture their products at scale while maintaining strict regulatory and quality standards.

Company size
10,001+
Company stage
IPO
Headquarters
Basel, Switzerland
Founded
1897

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