Associate Director of QA Computer Systems

About the Role

This is a senior quality assurance role focused on the full lifecycle of computerized systems in a regulated pharmaceutical environment. You will ensure critical systems remain compliant with GxP requirements as the organization transitions from clinical development to commercial operations. The role involves cross-functional collaboration with QA, Clinical, Commercial, IT, Finance, and external vendors to align systems with business and regulatory needs. It combines hands-on computer systems validation expertise with process improvement, vendor oversight, and scalable validation practices. The position is remote and offers an opportunity to contribute to quality systems supporting complex pharmaceutical development and commercialization activities.

Responsibilities

• Lead validation planning, execution, and documentation for new and existing computerized systems, including EDMS, QMS, ERP, and RIM platforms.
• Create, execute, and approve validation deliverables such as validation plans, risk assessments, user and system requirements, test scripts, traceability matrices, and validation summary reports.
• Maintain the validated state of QA computer systems through ongoing documentation, system reviews, lifecycle management, and quality oversight.
• Identify opportunities to streamline, standardize, and scale computer system validation processes while maintaining regulatory controls.
• Ensure data integrity principles are incorporated into computerized system processes and validation activities.
• Support vendor qualification, audits, inspections, and activities to demonstrate system compliance and quality.
• Lead system lifecycle activities, including risk assessments, change controls, audits, periodic reviews, and remediation.
• Manage vendor contracts and software licensing for computerized systems.
• Partner with IT to improve system functionality and end-user experience while maintaining compliance.
• Work with cross-functional stakeholders to align systems with business and regulatory needs.
• Support inspection readiness by maintaining validation documentation and preparing materials.
• Contribute to quality and validation strategies as business and system requirements evolve.

Requirements

• Bachelor’s degree in Computer Science, Information Technology, Engineering, or related field, or equivalent experience.
• 10+ years of computer system validation experience in regulated industries, with knowledge of validation methodologies and industry best practices.
• Strong understanding of FDA 21 CFR Part 11, GAMP 5, EU/EMA GMP Annex 11, and GxP requirements.
• Proven experience in quality assurance, computer system validation, or IT quality within life sciences.
• Demonstrated experience with Veeva Vault and Veeva Systems applications.
• Knowledge of software development lifecycle (SDLC) methodologies.
• Strong analytical, problem-solving, and decision-making skills with attention to detail.
• Excellent communication and collaboration skills across diverse stakeholders.
• Preferred: Experience with multiple GxP systems, employee/contractor management, Veeva Vault Administrator certification, electronic validation management, and proficiency in SharePoint and Microsoft Office.
• Ability to travel up to 15%.

Benefits

• Remote work opportunity.
• Base salary range: $170,000–$200,000 (varies by location, qualifications, and experience).
• Annual performance bonus eligibility.
• Medical, dental, and vision insurance.
• Disability, life, and long-term care insurance.
• Holiday pay and flexible vacation program.
• 401(k) plan with company matching.
• Educational assistance and fitness center reimbursement.

This position is listed on behalf of a partner company, who manages all applications and next steps.