Associate Director, Computer System Validation & Quality Compliance

Role Summary

Associate Director, Computer System Validation (CSV) & Quality Compliance leads enterprise‑level governance and strategy for validating and maintaining GxP computerized systems, with an emphasis on the Veeva Quality Suite. The role ensures digital quality solutions meet global regulatory requirements (FDA, EMA, ICH, GAMP 5), preserve data integrity, and maintain an inspection‑ready posture across the organization. You will partner with Quality, IT, Regulatory, Clinical, and business process owners to define system requirements, drive system implementations and major enhancements, and lead risk‑based validation practices.

Responsibilities

• Develop, evolve, and steward the corporate CSV/CSA strategy, ensuring alignment with enterprise digital strategy and Quality Management System objectives.
• Serve as the senior Quality authority for computerized systems validation, data integrity, and electronic system compliance.
• Oversee enterprise-wide governance programs, ensuring standardized, risk‑based approaches to system implementation and maintenance.
• Provide strategic guidance to senior leadership regarding system performance, risks, and compliance maturity.
• Lead planning, execution, review, and approval of validation deliverables across GxP systems.
• Oversee system lifecycle activities including impact assessments, change management, periodic reviews, audit trails, user access reviews, and system retirement.
• Promote and reinforce CSA‑aligned, risk‑based validation practices to streamline compliance and maximize efficiency.
• Ensure documentation quality and consistent application of SDLC principles across projects.
• Serve as the Quality SME for the Veeva Quality Suite, providing expert guidance on configuration, workflow optimization, and release readiness.
• Lead implementation, enhancement, and optimization of Veeva Vault modules and cross‑functional integrations.
• Drive automation and digitization initiatives that improve usability, compliance, and system performance.
• Partner with IT and Veeva administrators to maintain robust, compliant change control processes.
• Ensure all computerized systems maintain compliance with 21 CFR Part 11, EU Annex 11, GxP principles, and global data integrity expectations.
• Author, revise, and own Quality System policies and procedures related to electronic systems and validation.
• Represent Quality during internal audits, external regulatory inspections, and vendor assessments.
• Lead timely remediation, effectiveness checks, and continuous improvement initiatives.
• Provide oversight and trending for Quality Events related to system performance or compliance.

Qualifications

• Required: 8+ years of experience in the life sciences industry with strong GxP system experience.
• Required: Extensive leadership experience in cross‑functional implementation and validation of GxP computerized systems.
• Required: Deep expertise with Veeva Vault Quality Suite (QMS, Docs, Training, etc.).
• Required: Strong knowledge of global regulatory expectations and data integrity frameworks.
• Required: Demonstrated ability to lead enterprise programs, influence stakeholders, and drive compliant decision making.
• Preferred: Expertise with SaaS/cloud architectures and database compliance expectations.
• Preferred: Understanding of clinical data collection technologies and supporting data processes.
• Preferred: Familiarity with SDLC, Agile methodologies, CSV vs CSA principles and automated testing platforms.
• Preferred: Experience developing and interpreting Quality metrics such as KPIs and KQIs.
• Preferred: Excellent communication skills with the ability to collaborate, negotiate, and influence at all organizational levels.

Education

• Bachelor’s degree in a relevant scientific or technical discipline.

Skills

• GxP computerized systems validation and lifecycle management
• Veeva Quality Suite (QMS, Vault Docs, Training, etc.)
• Regulatory compliance (FDA, EMA, ICH, GAMP 5) and data integrity
• Quality management, Change Control, Deviations, CAPA, and audits
• SDLC, QA methodologies, risk-based validation
• Cross-functional leadership and stakeholder management
• Cloud/SaaS architectures and data governance
• Quality metrics (KPIs, KQIs) and performance reporting

Additional Requirements

• Remote work opportunities within the United States; some states are not eligible (e.g., Alaska, Arizona, Hawaii, Michigan, and Tennessee).
• Travel to the corporate location in Cambridge, MA several times per year, and attendance at other events as required, including possible travel by air or other means.
• Must have access to a work environment that meets role requirements (privacy, reliable internet, phone, and ability to communicate via video conferencing) at a remote location.