Sr Director, QA- GxP Systems

Location: Hybrid (3 days/week in Needham, MA; 2 days remote) Type: Individual contributor (no direct reports) Salary: $258,333 - $280,000 + 25% bonus Position Summary This role is a highly visible, senior quality systems professional who thrives in fast‑paced, resourceful environments. The hire will report directly to the SVP of Quality and act as a strategic partner across departments, independently owning vendor oversight, computer system validation, and overall GxP system effectiveness. The incumbent is a builder of systems, processes, and trust. What You’ll Own Quality Operations Leadership: Manage the end‑to‑end lifecycle of GxP systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part11 and modern industry standards. Vendor Oversight & Auditing: Lead qualification, risk assessment, and ongoing oversight of a diverse ecosystem of internal and external vendors—ranging from eQMS and EDMS to training systems, supply chain tools, and cloud‑based clinical applications. System Validation & Governance: Own all CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. Maintain inspection‑readiness at all times. Cross‑functional Enablement: Support scientific teams (PD, analytical, R&D) by ensuring vendor and data integrity for BLA‑enabling work. Bridge clinical and commercial quality expectations through practical systems thinking. Training & Continuous Improvement: Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the organization. Documentation & Record Management: Oversee document bundling, review, and archiving for key deliverables such as batch records, stability studies, and QA releases. Ensure audit‑ready files and streamlined workflows. What You Bring Bachelor’s degree in Life Sciences or a related technical field. 10+ years of experience in biotech/pharma Quality Assurance, with direct ownership of GxP systems and a proven track record managing audits, vendors, and validations. Expertise with eQMS, EDMS, training systems, and other regulated platforms; familiarity with stability, batch records, and clinical supply workflows. Background in clinical‑stage or hybrid clinical/commercial environments, with a hands‑on approach to QA operations and system management. Strong understanding of ICH, FDA, and Part11 requirements, and their application to cloud‑based, outsourced, and evolving environments. Experience in cross‑functional quality enablement, supporting teams such as PD, Analytical, and Clinical in system compliance. Critical thinker who can navigate ambiguity, prioritize work, and maintain momentum without daily direction. NOTE: All applicants must be authorized to work in the US and do not require sponsorship. Unfortunately, we are unable to provide sponsorship of any kind at this time. #J-18808-Ljbffr