Senior IT Quality Consultant (f/m/d)

Senior IT Quality Consultant- Engineering /regulatory / ICFR / GDPR / SCRUM

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Senior IT Quality Consultant

Background:
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 but the onboarding will be done from Basel/Kaiseraugst.

Perfect Candidate:
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.

Due to the short timeframe of recruitment, (we need someone latest mid-April), please focus your search on geographically available candidates (Switzerland or cross borders)

Tasks & Responsibilities:
* 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:

• 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 have:

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