Associate Director of QA Computer Systems

Accountabilities:: 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 appropriate regulatory controls. Ensure data integrity principles are consistently incorporated into computerized system processes and validation activities. Support vendor qualification, audits, inspections, and other activities required to demonstrate system compliance and quality. Lead ongoing system lifecycle activities, including risk assessments, change controls, audits, periodic reviews, and remediation activities. Manage applicable vendor contracts and software licensing for computerized systems. Partner with IT to improve system functionality and the end-user experience while maintaining compliance requirements. Work closely with cross-functional stakeholders to understand business and regulatory needs and ensure systems effectively support organizational objectives. Support inspection readiness by maintaining accurate validation and system documentation and preparing relevant materials and presentations. Contribute to quality and validation strategies as business and system requirements evolve during the transition from clinical development to commercial operations. Requirements: Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field, or equivalent professional experience. 10+ years of experience in computer system validation within regulated industries, with strong knowledge of validation methodologies, tools, and industry best practices. Strong understanding of applicable regulatory requirements and guidelines, including FDA 21 CFR Part 11, GAMP 5, EU/EMA GMP Annex 11, and broader GxP requirements. Proven experience in quality assurance, computer system validation, software testing, or IT quality within the life sciences industry. Demonstrated experience with Veeva Vault and Veeva Systems applications, including validation, quality assurance, or implementation activities. Knowledge of software development lifecycle (SDLC) methodologies and their application to regulated computerized systems. Strong analytical, problem-solving, and decision-making skills, with a high level of attention to detail and commitment to accuracy and quality. Excellent communication and collaboration skills, with the ability to work effectively across QA, IT, Clinical, Commercial, Finance, vendors, and other stakeholders. Experience working with multiple GxP systems and system implementations is preferred. Experience managing employees and contractors is a plus. Veeva Vault Administrator certification or similar credentials is preferred. Experience with electronic validation management is advantageous. Ability to adapt effectively within a fast-paced and evolving biotechnology environment. Proficiency with SharePoint, Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. Ability to travel up to 15% of the time. Benefits: Remote work opportunity. Base salary range of $170,000–$200,000, with compensation dependent in part on geographic location, qualifications, education, experience, and market factors. Eligibility for an annual performance bonus based on applicable plan terms and company and individual performance. Medical, dental, and vision insurance. Disability, life, and long-term care insurance. Holiday pay. Flexible vacation program. 401(k) plan with company matching contributions. Educational assistance benefit. Fitness center reimbursement. Equal opportunity employment and reasonable consideration for qualified applicants regardless of protected characteristics.