Quality Manager for Computerized System Validation (m/f/d)

Quality Manager for Computerized System Validation (m/f/d) – GxP / ISO 13485, FDA and Quality Systems Regulations / Medical Device Or IVD/ AI /Cloud solutions / CI/CD / English and German

Project:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Quality Manager for Computerized System Validation (m/f/d).

Background:
We are looking for an additional Infrastructure Partnering Team member in the area of Computerized System Validation (CSV). The position offers a close collaboration with our internal business partners in Global Customer Support, Roche Information Solutions but also interaction with Roche’s Integrated Informatics (IT). Together with our partners, we develop, derive and approve validation strategies based on cutting edge technology (like artificial intelligence).

The perfect candidate serves as an agile Quality Manager and enables our customers to deliver the required validation artifacts quickly and at the required quality standards. He/she performs document reviews/approvals in an independent, agile and holistic manner and has a profound understanding of our global quality management system. The perfect candidate can guide our IT colleagues when it comes to the needs of our quality quality management system.

Tasks & Responsibilities:
* Act as an independent Quality Partner for our qualification & validation business teams (in particular for computerized system validation CSV)
* Enable our business partners to develop and execute compliant and efficient validation strategies based on our global quality management system
* Perform comprehensive and independent feedback, review and approval of all validation and qualification artifacts involved in the system life cycle
* Based on a deep understanding of our global quality management system: act as ambassador of the global quality assurance processes and thereby enable our business partners to deliver high class medical products
* Shape, live and defend our global quality management system

Must Haves:
* Min. technical or scientific degree (FH/HF/University degree) or completed education in a technical profession (e.g. Computer Sciences, electrical engineering or IT)
* Min. 3-5 years practical expertise in the area of qualification and validation
* Experience in a GxP regulated environment
* Experience with quality management in the area of medical devices or in vitro Diagnostics (based on ISO 13485, FDA and Quality Systems Regulations)
* Fluency in English spoken and written
* German at least B1. Level (no certification needed)
* Pragmatically achieving highest quality standards while keeping stakeholders happy is your passion
* Good judgment, negotiation and communication skills, ability to prioritize tasks
* Autonomous, flexible, agile and open-minded team player with the ability to assert yourself

Nice to Have:
* Experience in the areas Artificial intelligence, Cloud solutions, Data integrity and CI/CD (continuous integration / continuous deployment) is considered a plus

Reference Nr.: 922329SDA
Role: Quality Manager for Computerized System Validation (m/f/d)
Industrie: Pharma
Workplace: Rotkreuz
Pensum: 80-100%
Start: 01.02.2023
Duration: 12++
Deadline: 25.01.2023

If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: +41 41 760 77 01.

About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.