Theradex Oncology · 15 hours ago
Lead Validation Specialist
Princeton, NJ
Full-time
Hybrid
Senior Level, Lead/Staff
$125K/yr - $150K/yr
8+ years expTheradex Oncology is focused on the development of cancer therapies, and they are seeking an experienced Lead Validation Specialist to join their team. In this role, you will provide project leadership for the validation team and ensure that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11.
Biotechnology
No H1B
Responsibilities
Provide project leadership for the validation team
Ensure that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11
Work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards
Create, execute, and maintain validation strategies and documentation where scope and requirements can shift quickly
Qualification
Required
Bachelor's degree
8+ years prior experience inclusive of computer systems validation
5+ Years relevant experience in Leading a Validation Team
Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+
Knowledge and understanding of Regulatory Guidelines for the use of computer systems
Experience working with GxP regulations and 21 CFR Part 11
Experience mentoring and coaching teams
Prior experience working in a Life Science regulated industry
Preferred
Prior project management experience
Benefits
Medical, dental and vision coverage
Life insurance
Disability insurance (STD/LTD)
Company matched 401(k)
Very competitive tuition reimbursement
Generous vacation/sick plans
Flexible work schedules
Employee discounts
Other company provided benefits
Company
Theradex Oncology
Theradex Oncology, your full-service CRO for all indications and modalities.
51-200 employees
Funding
Current Stage
Growth StageRecent News
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