Release Manager Business Systems (Computerized System Validation / Governance, Risk & Compliance)
Sonova Group
Staefa, Switzerland
1 gg fa

The global IT & quality processes of Sonova moves more and more towards one functional, collaborative operating unit. This very influential role owns part of responsibility of the IT quality management system, which covers several locations across the globe.

Our supportive and self-inspired team colleagues, located in our headquarters in Stäfa, Switzerland, Warsaw and Asia, awaits you in a friendly and collaborative atmosphere.

Your tasks

  • Perform release planning for major and minor releases with project managers
  • Identify areas for RM improvements in architecture and implement (Bundling Logic Synergies)
  • Support & monitor the business process creation phase (Macros & Micros incl. quality attributes in Solution Manager)
  • Prepare, align & communicate Refresh & Release schedules to global IT and Business
  • Ensures that all quality system methodologies are in compliance with government regulations and relevant standards such as ISO 13485, CFR 820, GMP, GDP, MDSAP, MDR, GRC
  • Validates quality processes by establishing quality system attributes; documenting evidence;
  • Writing, updating and / or reviewing and approving QMS Procedures.
  • Preparation, quality review and / or approval of release documentation in ALM tool according to CSV WI and RACI
  • Alignment and approval of transports in our ERP landscape according to CIT SOPs and Policies
  • Prepare, submit and present compliance methodology and docu. to notified bodies like TüV, FDA, Financial Auditor, incl. internal Audits
  • Help update eQMS Policies, SOPs and WI's with respect to application lifecycle management
  • Monitor Changes in quality and regulatory requirements and ensure efficient Implementation into respective processes and documentation
  • Ensure adequate execution of core quality activities : CAPA, Management review, Complaint, internal / third party Audit, Change Control, Documentation Control, Validation, Traceability
  • Your profile

  • Bachelor's degree in engineering, science or quality with 5+ years of relevant work experience in a regulated environment, preferably Medical Devices or equal education
  • Strong quality management experience supporting large multi-site, global organizations in life science industry with significant exposure to requirements of ISO 13485, CFR 820, GMP, GDP, MDSAP, MDR, GRC
  • Ability to promote high quality culture within the organization
  • Experiences on execution of core quality activities : CAPA, management review, complaint, internal / third party audit, change control, documentation control, validation, traceability
  • Familiar Agile project implementation methodologies
  • Hands-on project management experiences
  • Experience in organizational change / process change and how to manage transformations
  • Multiple end to end project lifecycle experience for implementing SAP business systems
  • Self-driven personality with high analytical and conceptual thinking, excellent interpersonal skills, team player, goal-oriented, problem solving, negotiation, with the ability to perform in a complex, global environment
  • Exceptional written and verbal communication skills
  • Ability to work independently and in a team environment.
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