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Manager - liasing it and qa - pharma compliance

Neuenburg
gloor&lang AG
Pharmaindustrie
EUR 120’000 pro Jahr
Inserat online seit: 6 September
Beschreibung

1 year contract – hybrid Job Model – French speaking desired

Are you passionate about bridging IT and Quality in a highly regulated environment? We are looking for an experienced Life Science professional to take on a pivotal role ensuring IT compliance and quality oversight across complex manufacturing systems.

What you’ll do

* Act as the key contact between IT and Quality, fostering a strong quality culture.
* Ensure compliance of site IT systems with GxP, EU-GMP Annex 11, and 21 CFR Part 11.
* Lead Computer System Validation (CSV) activities and support data integrity programs.
* Translate compliance requirements into test strategies (FAT, SAT, IQ, OQ, PQ).
* Partner with cross-functional teams and external stakeholders to drive compliance and continuous improvement.
* Support audits, infrastructure integration, and remediation projects.

What you bring

1. A degree in Life Sciences, Quality, Engineering, or related field.
2. 5–10 years of experience in the pharmaceutical, biotech, or life science industry, with at least 5 years in IT compliance, validation, or quality roles.
3. Solid knowledge of Quality Management Systems, GxP systems (MES, LIMS, etc.), and Data Integrity.
4. Strong IT foundation (OS, infrastructure, networking, systems).
5. Expertise in CSV and regulatory frameworks (21 CFR Part 11, EudraLex, MHRA).
6. Excellent communication skills, a structured and analytical mindset, and the ability to thrive in an international, multidisciplinary environment.

Why join?

This is a unique opportunity to contribute to high-impact manufacturing operations, ensuring compliance, data integrity, and patient safety. You’ll work in a dynamic environment that values ethics, collaboration, and continuous learning.

gloor&lang THE RIGHT CHOICE IN CONSULTATION FOR LIFE SCIENCE TALENTS

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