Support the compliant implementation of GxP computerized systems
(i.e., new, upgrades, changes, etc.) to ensure the approach and
execution aligns to industry as well as Biogen expectations.
Support globally as ITQ representative.
Represent ITQ on cross-functional teams in support of SDLC
activities for GxP applications, Drive the deployment of new or
modified GxP systems through review and approval of life cycle
deliverables in compliance with the governing regulations and
Perform and support all supporting quality related activities
associated with computerized systems, including periodic reviews,
exception management (deviation / CAPA), change management, risk
Support all Global Quality initiatives, including Data
Integrity, Computerized Systems and IT QMS implementation /
Assist with internal and external audits.
Attend department and project team meetings, system assessment
meetings, trainings, and other essential tasks. Routinely schedule
and complete multiple tasks and be timeline driven.
Provide quality assurance oversight for system related issues
(deviations, incidents, etc.) and application change controls
BA/BS in Life Sciences with 3+ years of hands-on experience
supporting implementation of IT computerized systems within a GxP
environment either as a CSV and/or Quality.
Ability to interpret regulatory guidance (GxP) and Biogen
policies and procedures into executable and defendable lifecycle
Depth of understanding of respective regulations governing
computer systems and controls such as FDA’s 21 CFR Part 11, EMA’s
Annex 11, and MHRA’s data integrity guidance.
Understanding of risk-based methodologies as it relates to
qualification and validation.
Knowledge of underlying infrastructure requirements supporting
Experience supporting health authority inspections.
As part of the IT Quality team, deliver technically robust and
compliant GxP computerized systems (CS) on cross-functional teams
in support of SDLC activities. Review and approve system life cycle
deliverables (SDLC) and activities to ensure that regulations,
protocols, procedures, and methodologies are followed, and that
appropriate and complete documentation is captured and reported to
support validation activities.