Sr Director, QA- GxP Systems

About the role

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.

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.

Qualifications

• All applicants must be authorized to work in the US and do not require sponsorship.