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Eisai US · 3 days ago
Senior Manager, Software Developer Quality Professional
Nutley, NJ
Full-time
Onsite
Senior Level
8+ years exp
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Responsibilities
QA approver for internal computer system validation efforts.
Act as liaison to the business for guidance and consultancy on system validation.
Support computer system audits for review of SDLC and data integrity controls.
Review CAPA and verification of CAPAs of system audits.
Support health authority audits/inspections for inspection readiness.
Qualification
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Required
Bachelor’s degree in associated functional disciplines including IT, Data Sciences and others.
Software development familiarity with both Agile and Waterfall methodology.
Knowledge of coding matrix and complexity measurements/determination.
Minimum 8 years experience in Pharmaceutical industry or similar.
Familiarity with regulations governing software development and validation.
Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently.
Ability to Travel (approximately 10-20%).
Preferred
Knowledge of Statistical Programming is preferred but not required.
Knowledge of GCP/GMP is preferred.
Auditing experience is preferred but not required.
Benefits
Equal Opportunity Employer
Travel Opportunities
Company
Eisai US
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. It is a sub-organization of Eisai.
1,001-5,000 employees
H1B Sponsorship
Eisai US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (9)
2022 (35)
2021 (22)
2020 (17)
Funding
Current Stage
Late StageLeadership Team
Tricia Brooks
VP & Head of Office, Government Affairs & Policy
Y
Yan Helen Hu
Associate Director, Strategic Medical Communication, Global Medical Affairs (NBG)
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