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

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.

• 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 Part 11 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.

• 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 Part 11 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.