Senior QA Computer System Validation Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Manage the validation, compliance, and lifecycle of GxP computer systems projects across GCP, GMP, and GLP environments.

• Supply QA oversight for business and CSV activities throughout the lifecycle of GxP computer systems.

• Ensure Quality oversight of GxP computerized systems that are operated, hosted, or maintained by external partners or vendors.

• Evaluate and approve CSV deliverables, IT change management requests, and quality records such as NCRs and CAPAs.

• Review plans and offer daily QA guidance for initial validation, steady-state activities, and controlled changes to GxP systems, focusing on clinical systems.

• Act as a subject matter expert in CSV requirements, data integrity controls, and relevant regulatory standards.

• Assist in the development or refinement of QA and CSV procedures and templates.

• Support qualification and requalification audits of IT vendors.

• Collaborate across functions and within Quality to identify improvements and implement enhancements.

• Aid inspection readiness initiatives, audits, and regulatory inspections.

• Perform additional duties as assigned by management.

⛳️ Requirements

• Bachelor's degree in life sciences, computer science, business, or a related field.

• A minimum of 5-7 years of experience in the biopharmaceutical industry, ideally in both large and small company settings.

• At least 4 years of experience in QA CSV.

• Strong background supporting computer systems utilized in clinical trials throughout all stages of development.

• Extensive experience in validating clinical systems (e.g., IRT, EDC, eTMF).

• Comprehensive knowledge of computer systems validation and computer software assurance.

• Experience with enterprise, quality, lab, and clinical systems to ensure compliance with FDA, EMEA, MHRA, and other regulatory standards.

• Proficient in ICH guidelines, 21 CFR Part 11, EU Annex 11, data integrity, and GAMP 5 concepts, applications, and best practices.

• Experience in supporting regulatory inspections and audits.

• Proven ability to apply risk-based approaches to information system selection, testing, implementation, and maintenance.

• Experience engaging with all levels of management and consulting with key business stakeholders.

• Strong team player with a customer service orientation and solution-focused mindset.

• Detail-oriented with the capability to work independently, as part of a multidisciplinary team, and with external partners and vendors.

• Excellent written and verbal communication skills; strong interpersonal abilities.

• Willingness to travel as required, less than 5% of the time.

• Ability to perform sedentary work and function in typical office or administrative settings.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance.

• Generous paid time off and holiday schedules.

• Opportunities for professional development and continuous learning.

• Collaborative and inclusive work environment.