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