Are you a seasoned professional with a background in clinical research and a passion for excellence? At InClin, a leading boutique CRO specializing in comprehensive clinical services, we’re on the hunt for a talented individual to join our team. If you have hands-on experience in the CRO space and are eager to contribute to impactful projects with a dedicated team, we want to hear from you! Discover how you can be a key player in our mission to deliver exceptional clinical solutions. We are seeking candidates experienced in the following:

Validating software systems used in CRO/GCP environments, including SAS (Statistical Analysis Software), electronic signatures, Argus, Veeva Vault, Box, EDC, LMS, and QMS systems.

If you feel like this is the right position for you, apply today!

JOB DESCRIPTION / SUMMARY

The Quality Assurance (QA) Validation Lead is responsible for the Computer System Validation (CSV) and change control processes in a GxP-regulated environment. The QA Validation Lead provides compliance guidance to InClin business leadership and CSV System stakeholders.

This position reports to the Senior Director, Quality Assurance.

RESPONSIBILITIES

The main responsibilities of this role include but are not limited to the following:

• Lead and oversee the Validation and Qualification processes for GxP Computer Systems and infrastructure, to ensure adherence to 21 CFR Part 11 Compliance, GAMP-5, EU Annex 11, and other relevant regulations.
• Recommend and review system-level configuration to fulfill security, data integrity, and regulatory requirements.
• Design Configuration Specifications (CS) in sandboxes and implement them into Validated Systems.
• Write, review, and approve CSV assessment documents, including GxP Computer System Risk Assessments, Part 11 Annex 11 Compliance Assessments, and GxP Computer System Data Integrity Assessments.
• Lead installation and testing activities including writing and overseeing Installation Qualification (IQ) Protocol and scripts, Operational Qualification (OQ) Protocol and scripts, Performance Qualification (PQ/UAT) Protocol and scripts, and Requirements Traceability Matrices (RTM).
• Author and approve Validation Plans and Validation Summary Reports.
• Document, evaluate, manage, and log GxP Computer System Change Control Requests (CCRs).
• Maintain an inventory of GxP Computer Systems, assess Validation status, and prioritize actions based on risk.
• Retire and archive IT GxP Computer Systems including retirement/migration planning and writing retirement summary reports.
• Provides input into IT procedures, Work Instructions (WIs), Guidance Manuals (GMs), and training materials for developing, maintaining, and using GxP Computer Systems.
• Evaluate potential new Computer Systems or software for GxP impact and provide risk-based Validation guidance.
• Review incidents and changes to Computer Systems for GxP impact, identifying and executing necessary Validation or Qualification requirements.
• Conduct periodic reviews of GxP Computer Systems and user access to ensure ongoing compliance with regulatory standards and audit readiness.
• Performs and/or assists with Qualification Audits of GxP IT System Service Providers to ensure that these organizations are operating in a compliant manner and maintaining the required quality standards.
• Maintain Master Validation Plan for company computerized systems.

EDUCATION AND EXPERIENCE REQUIREMENTS

• A minimum of two years of experience as a validation lead with direct experience in Validation in a clinical contract research organization, pharmaceutical, biotechnology, or regulated healthcare industry.
• Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21CFR Part 11, GAMP- 5, EU Annex 11, and other relevant regulations).
• Bachelor's degree or equivalent experience in computer science, information technology, or a related field.

KNOWLEDGE AND SKILLS REQUIREMENTS

• A high degree of proficiency in Microsoft Office Suite and Smartsheet
• Detail-oriented with a strong analytical mindset and problem-solving capabilities
• Strong analytical, interpersonal, writing, and problem-solving skills
• Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
• Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously
• Well-developed problem-solving skills combined with excellent interpersonal skills with the ability to work in a positive and collaborative fashion

The salary range is dependent on experience, but up to $109,000/annually.