Biogen Sr Associate II, IT Quality in Cambridge, Massachusetts
The main responsibility of this person is to provide guidance and review and approve documentation to qualify IT systems and infrastructure components. This person is also responsible for system validation and change control approval of IT systems documentation and change requests. Foundational and executable regulatory expectations for CS. Works with peers locally and globally, when necessary to ensure practices are consistent with requirements and expectations set forth within the governing QMS. May support health authority inspections as a Quality SME within the space. * Represent ITQ on cross-functional teams in support of SDLC activities for GxP applications, primarily focused on Corporate and Enterprise systems. Drive the deployment of new or modified GxP systems or supporting infrastructure platforms & components through review and approval of life cycle deliverables in compliance with the governing regulations and procedures. * Perform and manage all supporting quality related activities associated with computerized systems including periodic reviews, exception management (deviation / CAPA), change management, risk management, etc. for assigned systems in alignment with noted KPIs. * Support all Global Quality initiatives, including Data Integrity, Computerized Systems, Infrastructure, and IT QMS implementation / remediation. * Perform all assigned and required trainings to maintain 100% compliance. * Support GxP audit readiness activities * Minimally BA/BS in Life Sciences, Engineering, or IT with 3-5+ years of relevant industry experience required. * Hands-on experience supporting implementation of computerized systems within a GxP environment either as a CSV and/or Quality lead. * Ability to complete tasks independently and with limited oversight. * Ability to interpret regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation * Executable knowledge of respective regulations governing computer systems and controls such as 21 CFR Part 11, Annex 11, MHRA’s data integrity guidance, etc. * Understanding of risk-based methodologies as it relates to qualification and validation * Experience supporting health authority inspections * Good knowledge of IT infrastructure concepts and technologies *Why Biogen? * Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.