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Functional Lead QA CSV 80-100% (f/m/d)

Functional Lead QA CSV 80-100% (f/m/d)

Functional Lead QA CSV 80-100% (f/m/d)

Functional Lead QA CSV 80-100% (f/m/d)

Lonza AG

Bio- und Nanotechnologie

Visp

  • Art der Beschäftigung: Vollzeit
  • 100.000 CHF – 130.500 CHF (von XING geschätzt)
  • Vor Ort
  • Zu den Ersten gehören

Functional Lead QA CSV 80-100% (f/m/d)

Über diesen Job

Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.

This position serves as a key functional lead within QA Qualification & Validation, driving critical quality and compliance initiatives across the site. The role ensures robust CSV governance, strengthens Data Integrity and enhances the effectiveness and consistency of CSV processes through strong cross-functional collaboration.

What you will get:

  • An agile career and a dynamic work culture.

  • An inclusive and ethical workplace.

  • Compensation programs that recognize high performance.

In addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below.

Benefits in Visp: https://bit.ly/3wjkoFi

What you will do:

  • Define and maintain the site CSV strategy aligned with global standards, regulatory requirements (Annex 11, 21 CFR Part 11) and Data Integrity principles

  • Act as QA CSV authority in projects and ensure compliant system lifecycle management

  • Evaluate digital technologies and determine required CSV/DI controls

  • Ensure global alignment of CSV processes and drive harmonization

  • Make strategic decisions on CSV risks, validation approaches and quality strategies

  • Present local CSV strategies in audits/inspections and demonstrate alignment with global requirements to ensure Data Integrity.

  • Approve key CSV deliverables and ensure inspection‑ready documentation

  • Provide SME support, training and guidance across functions

What we are looking for:

  • Academic degree in Computer Science/ Engineering/ Life Sciences or similar

  • Significant experience in pharma/biotech QA, with a strong CSV and Data Integrity background

  • Deep knowledge of GxP, Annex 11, 21 CFR Part 11 and GAMP 5 is required

  • Strong understanding of system lifecycle and computerized systems

  • Strategic mindset, strong decision-making and stakeholder alignment skills

  • Experienced in audits/inspections related to CSV & DI

  • Excellent communication skills in both English & German

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.

Ready to shape the future of life sciences? Apply now.

Gehalts-Prognose

Unternehmens-Details

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Lonza AG

Bio- und Nanotechnologie

Köln, Deutschland

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