Change Control Manager

Change Control Manager - Project management/SAP/GxP/Rotkreuz

Background:

Global External Manufacturing is the competence center for parts and products in the diagnostic workflow, manufactured by external suppliers. This includes the development of new products, product care activities, the assurance of supply as well as the supplier selection and maintenance in close collaboration with Procurement.

The perfect candidate is someone who has knowledge and experience in GMP regulations and practices. Furthermore the candidate demonstrates flexibility, adaptability, proactivity and process thinking.

Tasks & Responsibilities:

• Managing change execution and change Coordination in the area of Global External Manufacturing with internal stakeholders (eg Quality Management) and external contract manufacturers
• Responsible for the efficient implementation of changes within Roche and also at the contract manufacturer
• Responsible for compliance application of the change and the corresponding KPIs
• Responsible for maintenance and preparation of the regulatory correct documentation, for example Change Request/Change
• Notification, Design Master Record, Design History File etc
• Planning and implementation of projects and work packages from product care projects with minimal supervision
• Being a proactive member of the squad
• Identification of process improvements in the working area (eg change process)

Must Haves:

• B.Sc. degree in Engineering, Natural Science or related disciplines or apprenticeship with high degree of subject matter expertise
• Min. 1-2 years of Project management experience
• Work experience in change management or in project and process management
• Practical experience in a regulated GxP environment, ideally in medical devices/IVD industry (ISO 13485, FDA 21 CFR 820, IVDR/MDR)
• First professional experience in document management within a regulated environment
• Good knowledge in SAP or comparable ERP system
• Very good user skills in MS Office and Google applications
• Very good communication skills in German (B2/C1) and English (C1) (spoken and

Reference Nr.: 924758SBI

Rolle: Change Control Manager

Industrie: Pharma

Workplace: Rotkreuz

Pensum: 70-100%

Latest Possible Start Date: ASAP-01.06.2026

Home Office: 2-3 days onsite

Planned Duration of Employment: 1 year

application deadline: 20.02.2026

Sollte diese Position Ihr Interesse geweckt haben, senden Sie uns bitte Ihr komplettes Dossier via den Link in dieser Anzeige.

Über uns:

ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von IT-Kandidaten für Auftragsarbeiten. Wir wurden 1997 von IT-Profis gegründet und wissen daher, wie wichtig die professionelle Unterstützung bei der Projektsuche und -arbeit ist.