myGwork - LGBTQ+ Business Community · 2 days ago
Sr Associate I, IT Quality
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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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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
Benefits
Medical insurance
Dental insurance
Life insurance
Long-term disability insurance
Short-term disability insurance
Vacation
End-of-year shutdown
401K participation
Matching contributions
Company
myGwork - LGBTQ+ Business Community
myGwork is the largest global platform for the LGBTQ+ business community.
Funding
Current Stage
Early StageTotal Funding
$4.77MKey Investors
24 HaymarketInnovate UK
2023-08-17Series Unknown· $1.66M
2023-08-17Grant· Undisclosed
2021-12-07Series A· $2.12M
Recent News
2024-04-10
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