Director / Sr Director Quality Assurance (GxP)
About the position NOTE: Title flexibility (Director vs. Senior Director) will be considered based on experience and impact. Location: Hybrid (3 days/week in Needham, MA; 2 days remote) Type: Individual contributor (no direct reports) This is a highly visible, unique opportunity for a seasoned quality systems professional who thrives in fast-paced, resourceful environments. You’ll report directly to the SVP of Quality and serve as a strategic partner across departments, while independently owning vendor oversight, computer system validation, and overall GxP system effectiveness. You are a builder—of systems, of processes, of trust. We don’t believe in micromanagement here. We believe in hiring people who take ownership, follow through, and bring integrity to every detail. If you're ready to roll up your sleeves, drive change, and help bring a life-changing oncology therapy to market, read on. This is not a role for the average. This is a role for someone ready to help launch a first-in-class therapy, and do it the right way. Responsibilities • 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. • 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. • 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. • 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. • Deliver GxP systems training and drive continuous improvement initiatives, trend analysis, and knowledge management across the org. • Oversee document bundling, review, and archiving for key deliverables like batch records, stability studies, and QA releases. Ensure audit-ready files and streamlined workflows Requirements • 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 how they apply to cloud-based, outsourced, and evolving environments. • Experience in cross-functional quality enablement, supporting teams like PD, Analytical, and Clinical in system compliance. • Critical thinker with the ability to 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. Apply tot his job