myGwork - LGBTQ+ Business Community · 2 days ago

Sr Associate I, IT Quality

United States

Full-time

Remote

Mid Level

$73K/yr - $109K/yr

4+ years exp

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Responsibilities

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.

Qualification

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LifesciencesPharma/Biotech industriesIT computerized systemsCSVQuality leadRegulatory guidance interpretationGxPBiogen policiesLifecycle documentationRegulations governing computer systemsFDA’s 21 CFR Part 11EMA’s Annex 11MHRA’s data integrity guidanceRisk-based methodologiesQualificationValidationUnderlying infrastructure requirementsSaaSAWSAzureIT project management methodologiesAgileServiceNowALMVeeva

Required

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 relates to qualification and validation.

Basic knowledge of underlying infrastructure requirements supporting GxP systems, and related IT technologies, e.g., SaaS, AWS, Azure, etc.

Experience with IT project management methodologies, such as Agile, and supporting IT systems, such as ServiceNow, ALM, Veeva, etc.

Bachelor’s Degree in Life Sciences, Engineering, or IT related discipline required