Responsibilities: Enterprise & Quality Risk Management Own and mature the enterprise risk management (ERM) program, including the annual risk assessment cycle, risk register maintenance, mitigation tracking, and reporting to executive leadership and the Audit Committee Facilitate risk assessments across functions, partnering with risk owners to define risk statements, scoring, mitigation plans, and escalation paths Lead quality risk management (QRM) in alignment with ICH Q9(R1), embedding risk-based decision-making into quality systems, deviation/CAPA management, change control, and supplier oversight Oversee risk-based vendor and CDMO oversight, including risk profiles and escalation frameworks for external manufacturing and testing partners Integrate commercial compliance risk considerations into the enterprise risk profile as the company approaches launch Develop risk dashboards, heat maps, and executive reporting that drive prioritization and resourcing decisions Inspection Readiness Lead the cross-functional inspection readiness program in support of BLA submission, including program governance, roadmap execution, and monthly dashboard reporting in partnership with the PMO Plan and execute the gap assessment portfolio across GMP, GCP, GLP, and quality system domains; drive risk-prioritized remediation to closure Design and lead internal and external mock inspections, including inspection logistics, front room/back room operations, SME preparation, and storyboard development Build inspection response infrastructure: document request workflows, escalation protocols, and real-time response management for PLI, PAI, and BIMO inspections Partner with CMC, Clinical, Regulatory, Medical Affairs, and TechOps to define function-specific readiness plans, document collection strategies, and training Establish readiness sign-off criteria and lead final organizational readiness verification ahead of submission and anticipated inspections Leadership & Cross-Functional Influence Present risk and readiness status to senior leadership, governance committees, and the Audit Committee; tailor messaging by audience from enterprise to product to function level Build, coach, and develop a small team as the function scales; manage consultants and contract resources as needed Champion a culture of risk awareness and inspection readiness as a continuous state, not a point-in-time event Contribute to Quality & Compliance strategic planning, including workforce planning, budgeting, and systems roadmaps Qualifications: This role owns the enterprise risk management (ERM) program and the cross-functional inspection readiness program, ensuring that the company identifies, prioritizes, and mitigates risks while building demonstrable readiness for FDA pre-license and pre-approval inspections (PLI/PAI), BIMO inspections, and global health authority engagements.