ro-389

EXPIRED – Senior IT Quality Consultant / ro-389

Location
CH-4303 Kaiseraugst
Start
01.04.2021
End
30.06.2021
Workload
100 %
All-in / Hour
please ask us
Total Hours
520 h
Deadline
Deadline
EXPIRED
ro-389

EXPIRED – Senior IT Quality Consultant / ro-389

Location
CH-4303 Kaiseraugst
Workload
100 %

Start

01.04.2021

End

30.06.2021

DEADLINE

Deadline
EXPIRED

  • CH-4303 Kaiseraugst
  • ro-389CH-4303 Kaiseraugst01.04.202130.06.2021100 % 520 hplease ask usDeadline
    EXPIRED

For our customer located in Kaiseraugst/Switzerland we are currently looking for a: Senior IT Quality Consultant (m/f/d)

  • Location: CH-4043 Kaiseraugst
  • Branch: pharma
  • Duration: 3 months, extension very likely

Tasks & Responsibilities

In this role, you are part of the IT Quality Assurance & Compliance unit in Diagnostics Informatics. Our ambition is to empower Diagnostics IT to deliver quality and compliance in an efficient way, right the first time.

Together with our Dia IT customers, we apply regulatory rules to modern technology like machine learning and new, agile development frameworks like SCRUM, DevOps, etc.

This position is an internal backfill. Please note the team is also recruiting for a permanent position. We are still opening the contract role to cover the longer internal process. The position will be supporting Diagnostics but the onboarding will be done from Basel/Kaiseraugst.

  • Provide compliance advice and support to ensure that activities are conducted in accordance to internal 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 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.

Must Haves

The perfect candidate is a senior profile with proven experience of quality assurance and compliance that can hit the ground running. We need someone with experience in regulatory compliance for Diagnostics and Medical Devices (please not experience in pharma will not match our need). This person should show experience as not only a validation lead (focusing on internal guidance) but also show knowledge of the regulatory background that led to the specific guidance.
This position is within Global IT and Business informatics, providing IT solutions for the business.

  • 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.)

Nice to Haves

  • Proven working experience in CSV in agile frameworks (SCRUM, SAFe)
  • Experience in SOC reporting ½
  • CISA certification
  • Lean Six Sigma certification
  • German speaking skills

Did we catch your interest?

The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).

Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.

Preferred Interview Dates

  • 2021-03-12

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