OBS! Ansökningsperioden för denna annonsen har
passerat.
Arbetsbeskrivning
We are looking for an IT Business Analyst Quality Systems (EDMS) with expertise in both information technology and EDMS (Electronic Document Management Systems). The IT Business Analyst Quality Systems (EDMS) will act as a bridge between senior stakeholders and the IT team. He/She will translate business needs into a functioning set of systems and hardware that will improve Galderma's Regulatory Affairs & Pharmacovigilance systems and overall business performance.
Responsibilities include but are not limited to:
Change Activities
* Integration of new solutions to existing systems
* Master data governance implementation
* Monthly Change Advisory Board meetings to drive evolutions/enhancements to the systems
* System life cycle management (investment strategy, upgrade roadmap, decommissioning
* Establishment of the sustain governance model around the systems
* Business partnership with user representatives to align our service level and activities with business expectations
* Support audits and inspections from regulatory authorities
Project Related Activities
* Plans, organizes and coordinates activities, participate to project plan and resources monitoring (new solutions deployments, upgrades, new regulations)
* Plan, prepare and moderate specifications workshops with business stakeholders in order to translate business requirements/wishes into Specifications
* Assess and execute on new regulatory requirement impact on systems
* Ensure compliance to Data Privacy regulations
Consultant Management
* Be the primary contact from IT for any task executed by external consultants, such as design change request, interface or report setup.
Budget and Procurement
* Comply with purchasing policies, Ensure Purchase Order in place with external consultants
* Ensures sustain costs are included in appropriate budgets, participate to cost tracking versus budget
To ensure success in this role you will have:
* 5 years in IT organization/pharma industry
* Experience of managing EDMS projects
* Experience working for Life Sciences companies a plus
* Knowledge of GxP and Pharma regulations
* Experience working with one or all the following systems: Documentum/D2, Veeva Vault
* Scrum expertise is a plus
* Fluency in English is a required, professional proficiency in French or Swedish a plus
* Degree in Computer Science or Information Systems or Life Sciences
Kontaktpersoner på detta företaget
Not Specified