- Region Basel
- Art des Vertrags Temporär - Vollzeit
- Tätigkeitssektor Informatik / Telekommunikation
As a preferred supplier for Roche in Basel, we are looking for a personality as Senior IT Quality Consultant (contract for 3 months, with extension if it is a fit for all parties) start date within 1-2 months. Remote/Home Office is possible.
- Provide compliance advice and support to ensure that activities are conducted in accordance to internal Roche procedures, international standards (GxP, ICFR, GAMP) and Health Authority regulations.
- Proactively reviews and analyze working practices, as well as results of inspections, audits and metrics/key performance indicators and advises the management team of potential impact from a compliance / process perspective.
- Provide IT Quality Assurance & Compliance support for DIA IT systems
- Oversee quality and compliance related activities, such as validation, qualification, system risk assessments, etc., for the assigned DIA IT systems; Provide consultancy to stakeholders regarding IT compliance, processes and standards considering the dynamic agile IT environment; Ongoing support of ITSM processes, e.g. Change- and Configuration management; Consulting of system support & project teams concerning IT Quality Assurance and Compliance topics (such as CSV, GDPR, ICFR, etc.).
- Create and Review IT Quality Management Processes
- Create and review components of the DIA IT Quality Management System (SOPs, TOPs, Templates, Checklists, etc.) and define IT Compliance guardrails and enablers; Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices.
- Ensure compliance to Roche IT procedures and regulatory requirements
- Participation in execution, documentation and tracking of internal and external IT audits (Co-Auditor); Participation in the development of compliance specifications, based on guidelines, legal requirements and policies and their review; Oversight or execution of periodic reviews of DIA IT systems.
- Provide coaching & training on IT procedures and regulatory requirements
- General coaching and training for governance topics like: (Built-In-) IT compliance, IT quality, data privacy and integrity; Contribution to the continuous improvement in the IT regarding the regulatory environment.
- Min 5 years of experience in a similar role with understanding of regulatory background leading to internal guidance
- Proven experience in regulatory compliance (CSV, Data Integrity, ICFR, GDPR, etc)
- Experience in Diagnostics/Medical Devices
- Experience with Agile frameworks
- Bachelor or Master Degree in Business Informatics or Engineering
- Proven adaption of regulatory compliance rules to new technologies (e.g. Cloud computing, RPA, machine learning) in a leading position
- Proven working experience in IT Quality Assurance functions (Validation Lead, Quality management, Auditing) in the medical device or pharmaceutical industry.
- Passionate about supporting and consulting IT delivery teams to strive for compliance in a collaborative way
- Eager to manage, improve, monitor and automate IT quality processes as a basis for data driven decision making (ITIL, COBIT certification are welcome)
- Experience in outsourcing of IT services (Offshoring, Cloud-Migration, testcenter,etc.)
- Proven working experience in CSV in agile frameworks (SCRUM, SAFe)
- Experience in SOC reporting
- CISA certification
- Lean Six Sigma certification
- German speaking skills
- Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
- Veröffentlicht am 8. März 2021
- Berater-in Jie Zhu