Sr IT Quality Control Specialist - Remote US

Location: Remote – US-based candidates only, no visa sponsorship available

Compensation: $95,000 – $115,000 annually

About the role

This role will lead technical work focused on cloud-enabled scalability, reliability, and delivery excellence. You will work across engineering, product, operations, and business stakeholders to translate complex requirements into practical technology solutions. The position offers the opportunity to influence architecture, execution quality, and the technology capabilities that enable long-term growth within a life sciences environment.

Responsibilities

• Provide quality assurance guidance on corporate and regulatory requirements specific to software validation
• Review validation lifecycle documents for compliance and accuracy per SOPs and regulations
• Guide quality processes through preparation, execution, and reporting of IQ, OQ, and PQ protocols
• Conduct periodic reviews of system documentation for ongoing compliance
• Approve change request documentation for validated systems and processes
• Fulfill other duties as assigned

Qualifications

• Bachelor's degree required; experience may substitute education
• Direct QA/QC experience with computerized systems validation
• Preferred experience in GCP clinical environments like CRO or SMO
• Over 5 years of experience focusing on FDA GxP and software validation
• Familiarity with EU regulations, especially Annex 11 is preferred
• Knowledge of software quality standards such as GAMP V, PIC/S, ICH
• Understanding of 21 CFR Part 11 requirements and software validation principles

Benefits

• Comprehensive benefits package to support physical, mental, and financial well-being
• Access to resources to ensure colleagues are healthy and supported in their roles