Description
Quality And Compliance Lead - Dutch Speaking
The skill Software Quality for the lead is focused on understanding SDLC and being able to coach people to apply it.
Also to identify issues with the SDLC and work on improvement of parts of the SDLC.
The lead should have a solid background knowledge for:
GxP (with Chemical and/or pharmaceutical supply chain business process knowledge) and (chemical/pharmaceutical) plant and distribution systems [first priority]
SOX (financial process, HR process) [second priority]
HCBI (health care compliance, CRM and related processes) [second priority]
Privacy (applications European privacy legislation) [second priority]
To support the functional knowledge,
IT oriented skills are useful:
ITIL (understanding of IT processes with some advantage of testing and project management skills)
COBIT (understanding and monitoring controls in IT processes - foundation for GxP and SOX IT implementation)
Software platforms: o SAP, Salesforce.com, MES (Werum PAS-X), Labvantage o IT technology understanding (computer, network, datacenter operations, operating system, DBMS, cloud computing solutions, big data, Agile development processes and solutions ) o Web systems and mobile applications
Project management IT tools that support SDLC processes like Quality Center, Quicktest Pro, Service Now, ClearQuest, SAP Solution Manager, JIRA, IBM JAZZ
Requirements development - good understanding and if possible experience with requirements gathering using use case methodology.
Quality Metrics (requirements quality and traceability, test and defect metrics, ) throughout the life cycle and capability to assist project teams in setting up, maintaining and reporting metrics, and to use the learnings to improve their process.
Requirements
Methodology/Certification requirements
Master and/or Bachelor Degree
Advanced course work in regulatory compliance and/or technical systems plus continued education in compliance or technical disciplines is preferred.
Non-Technical profile requirements
Excellent customer service, interpersonal, communication and team collaboration skills
Must be able to work on multiple simultaneous tasks with limited supervision
Strong tracking and coordination skills combined with good planning and organizational skills.
Strong analytical and problem-solving skills
Very result oriented
Natural team leader and people manager
Strong analytical skills with ability to identify SDLC process deviations and design new improved processes and coach teams for corrective actions or new processes.
Some flexibility in working hours is required (occasional over-time or weekend/holiday work)
Skills - nice to haves
FR or ES or DE
Required languages for this role
EN
NL