Data Integrity Program Lead - GMP QA (Visp)

Lonza Group Ltd.

Oberwallis

On-site

CHF 85,000 - 125,000

Full time

8 days ago

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Benefits offered by this job

Inclusive team
Agile culture
Competitive compensation

Job summary

Lonza Group Ltd. in Visp, Switzerland, seeks a Data Integrity professional to support the site's DI governance, promote ALCOA+ principles, and coordinate DI walkthroughs and improvements.

You will engage with cross-functional stakeholders and act as deputy for the Site Data Integrity Lead while ensuring robust compliance across GMP processes. This role emphasizes training, remediation activities, and continuous improvement within a dynamic, inclusive team at one of the world’s largest biologics

Qualifications

  • Academic degree in Life Sciences, Engineering, IT, Pharmaceutical Sciences, Quality Management, or related discipline.
  • Experience in a GMP-regulated pharmaceutical, biotechnology, or healthcare environment.
  • Good understanding of Data Integrity principles, ALCOA+, computerized systems, and applicable regulatory requirements.
  • Experience with deviations, investigations, CAPAs, change controls, and risk assessments.
  • Ability to identify compliance risks, evaluate issues, and support pragmatic solutions.
  • Strong communication and collaboration skills with cross-functional teams.
  • Experience supporting Data Integrity, compliance, computerized systems, CSV, Quality Systems, or related GMP activities is desirable.
  • Experience supporting audits, inspections, or regulatory interactions is desirable.
  • Fluency in English; German is an advantage.

Responsibilities

  • Support the site's Data Integrity governance program and contribute to the implementation of DI standards, initiatives, and site-specific improvement activities.
  • Promote Data Integrity awareness and ALCOA+ principles through training programs, coaching, and engagement with site functions across Visp.
  • Plan, coordinate, and support the execution of Data Integrity Walkthroughs across the Visp site and drive follow-up actions as required.
  • Support and coordinate Data Integrity assessments, remediation activities, and continuous improvement initiatives across GMP processes on site.
  • Provide Data Integrity support for deviations, investigations, change controls, CAPAs, quality risk assessments, audits, and inspections.
  • Deputize the Visp Data Integrity Community and act as deputy for the Site Data Integrity Lead, facilitating community meetings, stakeholder engagement, and site-wide alignment activities as required.

Skills

Data Integrity
Cross-functional collaboration
GMP compliance
Regulatory awareness
Audits and investigations

Education

Academic degree in Life Sciences, Engineering, IT, Pharma, Quality Mgmt, or related

Tools

CSV
Quality Management Systems
GxP software

Job description

Lonza Group Ltd. in Visp, Switzerland, seeks a Data Integrity professional to support the site's DI governance, promote ALCOA+ principles, and coordinate DI walkthroughs and improvements.

You will engage with cross-functional stakeholders and act as deputy for the Site Data Integrity Lead while ensuring robust compliance across GMP processes. This role emphasizes training, remediation activities, and continuous improvement within a dynamic, inclusive team at one of the world’s largest biologics

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