Remote Computer Systems Validation and Information Service Quality Assurance Director

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Fri, Oct 08, 2021

This job expires in: 12 days

Job Category: Information Technology

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Education Level: Some College, Bachelors

Job Summary

A biotechnology company has an open position for a Remote Computer Systems Validation and Information Service Quality Assurance Director.

Core Responsibilities Include:

  • Overseeing computerized systems validation (CSV) program and providing IS Quality oversight for non-GxP computerized systems operations
  • Overseeing the compliant execution of CSV activities for all GxP applications
  • Managing CSV function, including definition of the validation strategy and oversight of ongoing operations tasks

Applicants must meet the following qualifications:

  • Bachelor’s Degree (BS) from a four-year college
  • Minimum 10 years of experience in pharmaceutical/biotech industry leading IT Quality and/or Computer Systems Validation functions for SaaS delivery and Service Provider infrastructure qualification
  • Working knowledge of change control process for validated and non-validated IT systems
  • Experience using tools such as Veeva, Remedy, ServiceNow or equivalent
  • Ability to take responsibility for IT Quality Assurance covering non-GxP applications implementation and ongoing change control
  • Ability to act as the main point of contact for IS in interactions with regulatory agencies related to Computer Systems

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