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Data Integrity Program Manager

lonza · Visp

Nouveau
Mid 🇬🇧 English
CAPA Change control Quality risk assessment

Description du poste

About the role

Lonza is hiring a Manager, QA, Data Integrity Program Manager for its biologics manufacturing site in Visp, Switzerland, one of the largest in the world. You will support the site's Data Integrity (DI) program, working closely with the Site Data Integrity Lead and cross-functional stakeholders to ensure reliable, complete and accurate data, which is essential for product quality, patient safety, regulatory compliance and operational excellence.

Key responsibilities

  • Support the site's Data Integrity governance program and contribute to implementing DI standards, initiatives and site-specific improvement activities.
  • Promote Data Integrity awareness and ALCOA+ principles through training, coaching and engagement with site functions.
  • Plan, coordinate and support Data Integrity Walkthroughs and drive follow-up actions.
  • Support and coordinate DI assessments, remediation and continuous improvement across GMP processes.
  • Provide DI 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 and stakeholder engagement.

Required profile

  • Academic degree in Life Sciences, Engineering, Information Technology, Pharmaceutical Sciences, Quality Management or another relevant discipline.
  • Experience in a GMP-regulated pharmaceutical, biotechnology or healthcare environment.
  • Experience supporting Data Integrity, compliance, computerized systems, CSV, Quality Systems or related GMP activities.
  • Experience supporting audits, inspections or regulatory interactions is desirable.
  • Fluency in English is required; German is an advantage.

Required skills

  • Good understanding of Data Integrity principles, ALCOA+, computerized systems and applicable regulatory requirements.
  • Experience with quality processes such as deviations, investigations, CAPAs, change controls and risk assessments.
  • Ability to identify compliance risks and implement pragmatic solutions.
  • Strong communication and collaboration skills in cross-functional teams.

What we offer

  • A place in an inclusive, dynamic team within a diverse GMP manufacturing environment.
  • An agile career and a dynamic, inclusive and ethical workplace.
  • Compensation programs that recognize high performance.
  • Relocation assistance available for eligible candidates and their families.

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Source : ats:workday

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