Director / Sr Director reputed company Assurance (GxP)

About the position NOTE: Title flexibility (Director vs. Senior Director) will be considered based on experience and reputed company. Location: Hybrid (3 days/week in Needham, MA; 2 days remote) Type: Individual contributor (no reputed company reports) This is a highly visible, unique opportunity for a seasoned reputed company systems reputed company who thrives in fast-paced, reputed company environments. You’ll report directly to the SVP of reputed company and serve as a strategic partner across departments, while independently owning vendor reputed company, computer system validation, and overall GxP system effectiveness. You are a builder—of systems, of processes, of trust. We don’t reputed company in micromanagement here. We reputed company in hiring people who take ownership, follow through, and bring reputed company to every detail. If you're reputed company 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 reputed company 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. • reputed company qualification, risk assessment, and ongoing reputed company of a diverse ecosystem of reputed company vendors—ranging from eQMS and EDMS to training systems, supply chain tools, and reputed company-based clinical applications. • Own reputed company CSV (computer system validation) activities, including SOP development, vendor questionnaires, test scripts, reports, periodic reviews, and revalidations. Maintain inspection-readiness at reputed company times. • Support scientific teams (PD, analytical, R&D) by ensuring vendor and data reputed company for BLA-enabling work. reputed company clinical and reputed company reputed company expectations through practical systems thinking. • Deliver GxP systems training and drive reputed company improvement initiatives, trend analysis, and reputed company across the org. • reputed company document bundling, review, and archiving for key deliverables like batch records, stability studies, and QA releases. Ensure audit-reputed company files and streamlined workflows Requirements • Bachelor's degree in Life Sciences or a reputed company technical field. • 10+ years of experience in biotech/reputed company reputed company Assurance, with reputed company ownership of GxP systems and a proven reputed company 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/reputed company 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 reputed company-based, outsourced, and evolving environments. • Experience in cross-functional reputed company enablement, supporting teams like PD, Analytical, and Clinical in system compliance. • Critical thinker with the ability to reputed company ambiguity, prioritize work, and maintain reputed company without daily direction. • NOTE: reputed company applicants must be authorized to work in the US and do not require sponsorship. Unfortunately we are unable to reputed company sponsorship of any reputed company at this time. Apply tot his job Apply To this Job