Associate III, IT Quality

Job Description

• 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 procedures.
• Perform and support all supporting quality related activities associated with computerized systems, including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems and IT QMS implementation / remediation activities.
• 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

Qualifications

• 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 documentation.
• 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 GxP systems.
• Experience supporting health authority inspections.

Additional Information

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.