IT Quality and Validation Manager

Ort: Switzerland - Glattbrugg/Zurich

Funktion: Information Technology

Senioritätslevel: Manager

Ihr Profil

Vifor Pharma, a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, is experiencing rapid growth due to pipeline realization and optimization. As such we are seeking at our headquarters in Glattbrugg an IT Quality and Validation Management professional from a pharmaceutical background with exceptional understanding of IT Risk and compliance in a GxP environment. Computer Systems Validation (CSV) is also required as is defense of the global IT systems in audits and inspections.

Main Accountabilities 
  • Responsible for the IT QM processes & governance, including concepts & policies
  • Manage remediation efforts from audits & inspections and work on deviations
  • Contact and confer with validation experts and identify and support dedicated resources
  • Investigate on Quality & Regulatory aspects 
  • Keep current with changing and emerging regulations
  • Share knowledge of specific Quality aspects in IT and across other parts of the organization
  • Assess current quality compliance situation and identify weaknesses or shortfalls
  • Implement missing or stronger regulatory/quality compliance controls/policies
  • Manage internal Quality audits
  • Manage training for IT internal and external onboarding on IT Quality & regulatory aspects.
  • Manage and improve the quality of external IT Validation Managers
  • Manage system classification and supplier assessments
  • Manage CSV validation strategy & validation lead activities in projects
  • Define principles and guidelines for compliant IT Services in operation
Key Tasks 
  • Manages day-to-day IT operations for IT Compliance and Risk Management
  • Mentors other units in IT Compliance and Risk Management
  • Supports and coordinates the validation of quality relevant applications
  • Drive and facilitate the creation of relevant IT SOPs
  • Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables
  • Coordinates documentation, testing, and change management activities to ensure compliance with IT, business and regulatory needs
  • Manage the VMP, CSV and SysOP SOP from IT
  • Manage external CSV Validation Managers together with Line Manager
  • Manage IT Training and the LMS setup for IT (internal / external)
  • Represent IT as SPOC in internal and external inspections/audits
  • Support the IT IRM (Information Risk Management) Framework
  • Support IT in CAPA / Deviation relevant activities
For this important and challenging role, we are looking for an experienced and solution-oriented candidate, who brings excellent conceptual and analytical skills as well as a structured and proactive and hands-on approach. 

Minimum Requirements
  • Bachelor’s degree or similar
  • Preferred: Additional training in IT Information Risk Mgmt., e.g. Cobit.
  • Minimum 2 years experience in managing complex CSV projects
  • Minimum 3 years experience in pharmaceutical industry
  • Minimum 5 years experience in Validation Manager / Lead function
  • Have an excellent understanding of healthcare regulations (GAMP, 21CFRpart11, GMP)
  • Very good quality assurance & pharmaceutical production process understanding
Preferred Requirements
  • Knowledge of PMI or other project management methodology
  • Experience with ITIL processes
  • Experience in an IT Management position
  • Knowledge of the German and / or French language
  • Experience with IT information risk management
  • Experience with GDPR
  • Experience with ERP valition, e.g. SAP
Beside these requirements, you display strong organization and time management skills and the ability to adapt to new systems and processes. With your excellent interpersonal skills, you are able to interact productively and effectively influence others.

Über uns

Die Vifor Pharma Gruppe ist ein globales Spezialitäten-Pharmaunternehmen. Sie hat sich zum Ziel gesetzt, globale Marktführerin in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu werden. Das Unternehmen ist der bevorzugte Partner für Pharmaprodukte und innovative, patientenorientierte Lösungen. Die Vifor Pharma Gruppe will Patienten mit schweren und chronischen Krankheiten auf der ganzen Welt dabei helfen, ein Leben in besserer Gesundheit zu führen. Das Unternehmen entwickelt, produziert und vermarktet pharmazeutische Produkte für eine optimale Patientenversorgung. Die Vifor Pharma Gruppe nimmt in allen ihren Kerngeschäften eine führende Position ein und besteht aus folgenden Unternehmen: Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma (ein gemeinsam mit Fresenius Medical Care geführtes Unternehmen); und OM Pharma.

Die Vifor Pharma Gruppe hat ihren Hauptsitz in der Schweiz und ist an der Schweizer Börse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348) kotiert.

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