Remote US Position

Full Health Benefits / 401k / Holiday Pay

Exempt Salary: $99k - $109k annually, dependent on experience

**Job Summary:**
The Clinical QA Validation Lead is responsible for overseeing the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. This role involves providing compliance guidance to business leadership and CSV stakeholders while ensuring adherence to relevant regulations.

**Responsibilities:**
- Lead and oversee the Validation and Qualification processes for GxP Computer Systems and infrastructure to meet regulatory requirements.
- Recommend and review system-level configurations for security, data integrity, and regulatory compliance.
- Design Configuration Specifications (CS) and implement them into Validated Systems.
- Write, review, and approve CSV assessment documents including risk assessments and compliance assessments.
- Lead installation and testing activities, author and approve Validation Plans and Reports.
- Document, evaluate, and manage GxP Computer System Change Control Requests (CCRs).
- Maintain an inventory of GxP Computer Systems, assess Validation status, and prioritize actions based on risk.
- Provide input into IT procedures, Work Instructions, and training materials for GxP Computer Systems.
- Evaluate new Computer Systems for Validation impact and provide guidance.
- Conduct reviews of GxP Computer Systems for ongoing compliance and audit readiness.
- Perform Qualification Audits of IT System Service Providers.
- Maintain Master Validation Plan for company computerized systems.

**Qualifications:**
- Minimum of two years of experience as a validation lead in clinical research, pharmaceuticals, biotechnology, or regulated healthcare.
- Strong understanding of regulations relating to Computer System Validation and Quality Management Systems.
- Bachelor's degree in computer science, information technology, or related field.
- EXPERIENCED Validating software systems used in CRO/GCP environments, including SAS (Statistical Analysis Software), electronic signatures, Argus, Veeva Vault, Box, EDC, LMS, and QMS systems REQUIRED

**Skills Requirements:**
- Proficiency in Microsoft Office Suite and Smartsheet.
- Detail-oriented with strong analytical and problem-solving capabilities.
- Self-motivated with an entrepreneurial style and positive attitude.
- Excellent project management skills and ability to lead cross-functional teams.
- Strong interpersonal and collaborative skills for effective teamwork.