Lead Validation Specialist

Theradex Oncology • NJ

77d • $125,000 - $150,000

About The Position

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Requirements

• 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+.
• Experience working with GxP regulations and 21 CFR Part 11.
• Experience mentoring and coaching teams.
• Prior experience working in a Life Science regulated industry.
• Prior project management experience, preferred.

Nice To Haves

• Prior project management experience.

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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree