Manager of IT Regulatory Affairs

vor 1 Tag


Rheinfelden Aargau, Aargau, Schweiz Jobcloud Vollzeit
Key Responsibilities

As an IT Compliance Specialist, you will be responsible for leading the qualification and validation activities of computerized systems throughout their lifecycle. This involves conducting periodic reviews on the qualification status of these systems, as well as leading IT Change Control for all On-Premise and Cloud systems.

Additional responsibilities include performing supplier qualifications, supporting the optimization of IT and business processes in both GxP and non-GxP areas, creating and conducting CSV-related trainings, and assisting businesses with implementing GxP and non-GxP systems. You will also serve as a contact person for all departments and affiliates regarding IT compliance matters.

Qualifications for this position include a Bachelor's degree in IT or life sciences with CSV experience in Pharma required, as well as more than 5 years of work experience in CSV is essential. Experience in GMP, GAMP5, CFR21 Part 11 is necessary, and fluency in English (written and spoken) and German (written and spoken) is expected. A proactive work style with good communication skills is required, and excellent team player capabilities are necessary.

We offer a competitive compensation package and a comprehensive benefits program that includes a pension fund, continued payment of salary in the event of illness and accident, language courses, leadership trainings, individual trainings, summer BBQs, and year-end parties.

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