Vacancy caducado!
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. 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. Support internal and external audits as the IT Quality point of contact. To complete tasks independently and with limited oversight with local and global regulatory guidance (GxP) and Biogen policies and procedures into executable and defendable lifecycle documentation. Coordination with Vendor for SaaS solutions, to meet all define Biogen requirements supporting GxP systems.
Must have 10 or more years of hands-on experience supporting implementation of IT 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.
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.
Knowledge of key compliance components.
Experience supporting health authority inspections.
Bachelor’s Degree (BS) from a four (4) year college or university with as emphasis in Engineering, Life Sciences or IT related discipline with relevant experience. Advanced degree preferred.As part of the IT Quality team (located in Cambridge, MA), the ideal candidate will deliver technically robust and compliant GxP computerized systems (CS) that withstand audits, both internal and external.The Sr. Associate III, IT Quality (Quality Systems and Enterprise Management) is expected to have working-level knowledge of CS and supporting GxP applications, including the quality systems supporting it (i.e., change management, exceptions management, risk management).
Vacancy caducado!