3 дня назад
Senior Manager, IT Operations for Labs (Biotechnology)
108 000 - 206 100$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, IT Operations for Labs (Biotechnology): Leading maintenance, support, and development of validated laboratory IT applications including Empower CDS and SDMS with an accent on audit readiness, regulatory compliance, and data integrity. Focus on managing IT Applications analysts, supporting FDA inspections, maintaining 21 CFR Part 11-compliant systems, and coordinating vendors and global QC systems.
Location: Troy, New York, United States. Work model: Monday–Friday, 8:00 a.m.–4:30 p.m.; the role is expected to be performed onsite.
Salary: $108,000–$206,100 annually.
Company
Biotechnology company developing and commercializing medicines for serious diseases through research-led drug discovery and development.
What you will do
- Lead and develop a team of IT Applications analysts through coaching, performance management, mentoring, and goal setting.
- Oversee the maintenance, support, and development of business-critical laboratory applications, including Empower CDS and SDMS.
- Drive audit readiness and act as a key contact during FDA inspections and internal audits.
- Ensure applications remain validated, compliant, and aligned with 21 CFR Part 11, ALCOA+ principles, SOPs, and data-integrity requirements.
- Maintain system documentation, including user, design, configuration, and test specifications.
- Manage vendors, operational metrics, continuous-improvement initiatives, and coordination with global QC systems counterparts.
Requirements
- Bachelor’s degree in Information Technology, Science, Engineering, Computer Science, or a related field; equivalent experience may be considered.
- Manager level: 7+ years of relevant experience and 3+ years managing teams.
- Senior Manager level: 8+ years of relevant experience and 4+ years managing teams.
- Strong knowledge of cGMP, GAMP, 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity in biopharmaceutical production.
- Experience leading teams through FDA inspections and internal audits.
- Must work onsite in Troy, New York, United States, Monday–Friday, 8:00 a.m.–4:30 p.m.
Nice to have
- Experience supporting applications in a regulated GMP laboratory or IT environment.
- Knowledge of Regulatory Asset Manager systems.
Culture & Benefits
- Inclusive workplace with equal-opportunity employment practices.
- Comprehensive rewards may include bonuses, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
- Background checks may verify identity, right to work, and educational qualifications where required by law.
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