Associate Director, GCP Compliance

This role can be remote, hybrid or based in our Philadelphia, PA headquarters. Responsibilities: Risk-Based QMS Leadership: Build and maintain a risk-based QMS framework emphasizing CtQ factors, risk identification, control, communication, and continuous review in alignment with E6(R3) principles. Controlled Document Governance: Manage controlled document lifecycles (SOPs, WIs, forms) ensuring alignment with regulatory expectations and consistent application across functions. Data Integrity & Systems Oversight: Oversee GxP-relevant computerized systems ensuring compliance with ALCOA++ principles, validated configurations, and secure audit trails. Training Program Ownership: Maintain role-based training curricula; ensure completion, tracking, and effectiveness; incorporate risk-based training needs and process updates. Change Control, Deviations & CAPAs: Lead deviation management, root cause analysis, and CAPA development; conduct trend analyses to identify systemic risks and preventive actions. TMF Quality & Inspection Readiness: Drive TMF oversight with risk-based QC, completeness checks, and metrics ensuring 24/7 inspection readiness; manage document governance and version control. Vendor & CRO Oversight: Apply proportionate oversight models; define quality agreements; monitor vendor metrics, audit outcomes, and compliance to CtQ activities. Cross-GxP Integration: Align clinical (GCP) and manufacturing (GMP) documentation, ensuring traceability, record integrity, and lifecycle control across study materials and data. Metrics & Management Review: Develop leading and lagging indicators for QMS performance; report outcomes during management reviews to support continuous improvement. Culture of Quality: Promote an accountability-driven, learning-oriented culture that prioritizes patient safety, data integrity, and operational transparency. Qualifications: