Sr Associate I, IT Quality

Job Description

About This Role 

As part of the IT Quality team, the Sr. Associate I, IT Quality will deliver technically robust and compliant GxP computerized systems (CS) on cross-functional teams in support of SDLC activities. This individual will 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, including foundational and executable regulatory expectations for CS. The Sr. Associate I, IT Quality will work with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS. This role reports into the Sr Manager, IT Quality.

What You’ll Do 

• 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.
• Support the compliant implementation and maintenance 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.
• Support all Global Quality initiatives, including Data Integrity, Computerized Systems support and IT QMS implementation / remediation.
• Provide quality assurance oversight for system related issues (deviations, incidents, etc.) and application change controls.
• Support GxP audit readiness activities and assist with internal and external audits/inspections.

Qualifications

Who You Are 
You are experienced in supporting implementation of IT computerized systems within a GxP environment. You are customer service oriented, possess strong communication skills and known for having good judgment in making critical business decisions. You are well versed in infrastructure and vendor hosting requirements supporting GxP systems and IT project management methodologies. 

• At least 4 years of related experience. Background in Lifesciences and/or Pharma/Biotech industries or experience in a highly regulated industry required.
• Must have hands-on experience supporting implementation of IT computerized systems (i.e., IT systems) within a GxP environment either as a CSV and/or Quality lead. 
• 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 …