Manager IT Compliance 100% H/F - Albedis SA

apartmentAlbedis Lausanne placeAreuse calendar_month29.08.25

DESCRIPTION DE LA MISSION

Act as the primary point of contact between the local IT team and QA Compliance.
Ensure IT systems meet GMP and CSV requirements (21 CFR Part 11, EU-GMP Annex 11).
Drive a culture of quality and ethics across all site IT initiatives.
Support audits, Data Integrity programs, and infrastructure integration activities.
Translate compliance requirements into testing strategies and documentation (FAT, SAT, IQ, OQ, PQ).
Act as a Quality Ambassador, providing guidance to internal stakeholders and third-party vendors.

Collaborate across functions to support the implementation and validation of critical IT systems (e.g., MES, LIMS).

PROFIL ATTENDU
Bachelor's degree in Science, Engineering, Quality or related field.
5+ years of experience in the pharmaceutical, biotech, or life sciences industry and in a similar IT Quality/Compliance role.
Strong knowledge of CSV, GxP systems, and Data Integrity.

Solid understanding of IT infrastructure, networking, and system design.

Expertise in regulatory frameworks: 21 CFR Part 11, EudraLex, MHRA.

Excellent communication and problem-solving skills.
Fluent in English; French is a strong plus.

Independent, hands-on, and able to manage multiple projects.

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