Secura Bio, Inc.

Director

• Lead day-to-day Quality operations, overseeing GxP activities to support commercial manufacturing and ongoing clinical trials, including compliance support and issue management
• Own and manage the Quality Management System (QMS), ensuring compliance with global regulatory standards and alignment with corporate goals
• Develop and oversee CAPA plans in response to Quality events, audits, and inspections; monitor CAPA effectiveness and closure
• Manage quality oversight of CMOs, CROs, and other vendors; coordinate external audits and ensure effective supplier qualification and monitoring
• Implement and maintain quality metrics, systems, and documentation associated with commercial product supply and clinical trials, including procedures, processes, tests, equipment, materials, regulatory requirements, and staffing proficiency
• Provide leadership and strategic direction across Quality functions including Quality Systems, QA Operations, Supplier Quality, and Clinical Quality
• Partner with Regulatory Affairs, CMC, Clinical, Supply Chain, and other cross-functional teams to ensure end-to-end GxP compliance
• Drive continuous improvement initiatives to optimize quality processes, risk management, and inspection readiness
• Serve as the point person for inspection readiness and regulatory agency inspections related to quality systems

Director – Quality

• Set the national vision, strategy, and operating model for the U.S. MSL organization, aligned to medical and corporate priorities.
• Lead, coach, and develop a geographically dispersed team of MSLs; recruit, onboard, and retain top scientific talent.
• Define and govern standards for scientific engagement, including KOL strategy, external engagement planning, documentation, and compliant scientific exchange.
• Oversee relationship-building with national, regional, and local KOLs, academic centers, and community networks to ensure consistent, high-quality scientific dialogue.
• Partner with Medical Affairs leadership to develop and execute the integrated medical plan; ensure field priorities translate into clear territory plans and deliverables.
• Establish mechanisms to capture, synthesize, and communicate field insights to inform cross-functional decision-making, evidence generation, and strategy refinement.
• Serve as a senior scientific resource for major initiatives including congress strategy and execution, advisory boards, internal training, and strategic planning forums.
• Collaborate cross-functionally with Clinical Development, Regulatory, Commercial, and Market Access to support clinical trial awareness, launch readiness, and post-launch evidence plans.
• Ensure the MSL act as Key Contact Persons in the management of investigator-sponsored research proposals, ensuring timely review, communication, and alignment with corporate research priorities.
• Own MSL performance measurement and impact reporting (KPIs/OKRs), including quality metrics, insight value, scientific engagement outcomes, and continuous improvement plans.
• Oversee MSL tools and processes (e.g., CRM/activity tracking), field communications, and training to drive consistency, efficiency, and audit readiness.
• Manage the national MSL budget and resourcing plans (headcount, territories, congress coverage) in partnership with Medical Affairs operations.

Director – Quality

Senior Director, Medical Science Liaisons – MSLs