Senior Director, Quality Systems (USA)

Senior Director, Quality Systems (global leadership) Role Summary Provide enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms to support compliant, efficient, modern GxP quality processes. Key Responsibilities Lead global QMS systems strategy, investment roadmap, and governance. Plan, execute, sustain, and continuously improve QMS system initiatives and investments. Serve as business owner for core QMS systems/platforms (LMS, EDMS, QMS workflows). Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to align systems to process needs and enterprise priorities. Ensure strategic system investments meet GxP, computerized system validation, and quality requirements. Develop scalable operational services/support models for consistent, efficient, compliant QMS operations. Represent IM Quality Systems in enterprise transformation and governance. Lead and develop a global team; drive accountability, collaboration, inclusion, and high performance. Monitor internal/external quality systems and digital trends; identify simplification, standardization, innovation, and value creation. Develop dashboards/metrics and executive updates on system performance, progress, risks, and opportunities. Travel: up to 10% domestic and international. Qualifications Bachelor’s degree required. Minimum 12 years in Quality Systems/Quality Operations/digital quality/program management/transformation or related regulated environment. Experience with QMS platforms supporting GxP. Demonstrated experience shaping roadmaps, leading investments, and translating business needs into plans. Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement. Ability to influence and align senior leaders and global matrixed stakeholders. Strong strategic, communication, presentation, analytical, and decision‑making skills. Experience leading teams and developing talent. Preferred Qualifications Advanced degree (M.S., MBA, Ph.D., Pharm.D., or equivalent). Experience in pharmaceuticals/healthcare/medical technology. Experience with QMS platforms (e.g., Veeva, TrackWise, ComplianceWire, EDMS, LMS). Experience delivering enterprise‑scale transformation with digital/technology/process/quality partners. Required/Preferred Skills Business Alignment, Compliance Management, ISO 9001, Leadership, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Stakeholder Engagement, SOPs, Statistical Process Control (SPC), Systems Thinking, Technical Writing, Developing Others, Inclusive Leadership. Benefits (time off) Vacation: 120 hours/year; Sick time: 40 hours/year (CO: 48; WA: 56); Holiday pay (incl. Floating Holidays): 13 days/year; Work/Personal/Family Time: up to 40 hours/year; Parental Leave: 480 hours; Bereavement Leave: 240 hours immediate family / 40 hours extended; Caregiver Leave: 80 hours (52-week rolling period); Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year. #J-18808-Ljbffr Scorpion Therapeutics