Senior Director, Quality Systems (USA)
Johnson & Johnson
June 26, 2026
Remote friendly (San Diego, CA)
United States
Operations
Role Summary
Senior Director, Quality Systems provides enterprise leadership for the strategy, roadmap, operation, and sustainment of core Quality Management System (QMS) systems and enabling platforms to enable compliant, efficient, modern GxP quality processes across Innovative Medicine.
Key Responsibilities
- Lead global QMS systems strategy, investment roadmap, and governance.
- Oversee planning, execution, sustainment, and continuous improvement of QMS initiatives/investments.
- Serve as business owner for core QMS systems (LMS, EDMS, QMS workflows) and related operational capabilities.
- Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to align systems to process needs and enterprise priorities.
- Provide quality leadership for strategic system investments (GxP, computerized system validation, quality requirements).
- Develop scalable operational services/support models for compliant QMS operations.
- Represent IM Quality Systems in enterprise transformation and senior leadership discussions.
- Lead and develop a global team; monitor trends and develop dashboards/metrics for QMS performance, risks, and opportunities.
Qualifications
- Bachelor’s degree required.
- Minimum 12 years in Quality Systems/Quality Operations, digital quality, program management, transformation leadership, or related regulated environment.
- Experience with QMS platforms supporting GxP processes.
- Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement.
- Ability to influence senior/global/matrixed stakeholders; strong strategic, communication, analytical, and decision-making skills.
- Ability to lead teams and manage multiple priorities.
Preferred Qualifications
- Advanced degree (M.S., MBA, Ph.D., Pharm.D., or equivalent).
- Experience in pharmaceuticals/healthcare/medical technology.
- Experience with Veeva, TrackWise, ComplianceWire, EDMS, LMS, or similar.
- Experience delivering enterprise-scale digital/technology/process transformation.
Travel
- Up to 10% domestic and international travel.
Benefits (time off, subject to policy/date of hire)
- Vacation: 120 hours/year; Sick: 40 hours/year (Colorado: 48; Washington: 56); Holiday pay (incl. floating): 13 days/year; Work/Personal/Family Time: up to 40 hours/year; Parental Leave: 480 hours; Bereavement Leave: 240 hours (immediate) / 40 hours (extended); Caregiver Leave: 80 hours (52-week rolling); Volunteer Leave: 32 hours; Military Spouse Time-Off: 80 hours.
Required/Preferred Skills (as listed)
Business Alignment, Compliance Management, Compliance Policies, Developing Others, Inclusive Leadership, ISO 9001, Leadership, Process Improvements, QC, Quality Standards, Quality Systems Documentation, Stakeholder Engagement, SOP, Statistical Process Control (SPC), Systems Thinking, Technical Writing
Senior Director, Quality Systems provides enterprise leadership for the strategy, roadmap, operation, and sustainment of core Quality Management System (QMS) systems and enabling platforms to enable compliant, efficient, modern GxP quality processes across Innovative Medicine.
Key Responsibilities
- Lead global QMS systems strategy, investment roadmap, and governance.
- Oversee planning, execution, sustainment, and continuous improvement of QMS initiatives/investments.
- Serve as business owner for core QMS systems (LMS, EDMS, QMS workflows) and related operational capabilities.
- Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to align systems to process needs and enterprise priorities.
- Provide quality leadership for strategic system investments (GxP, computerized system validation, quality requirements).
- Develop scalable operational services/support models for compliant QMS operations.
- Represent IM Quality Systems in enterprise transformation and senior leadership discussions.
- Lead and develop a global team; monitor trends and develop dashboards/metrics for QMS performance, risks, and opportunities.
Qualifications
- Bachelor’s degree required.
- Minimum 12 years in Quality Systems/Quality Operations, digital quality, program management, transformation leadership, or related regulated environment.
- Experience with QMS platforms supporting GxP processes.
- Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement.
- Ability to influence senior/global/matrixed stakeholders; strong strategic, communication, analytical, and decision-making skills.
- Ability to lead teams and manage multiple priorities.
Preferred Qualifications
- Advanced degree (M.S., MBA, Ph.D., Pharm.D., or equivalent).
- Experience in pharmaceuticals/healthcare/medical technology.
- Experience with Veeva, TrackWise, ComplianceWire, EDMS, LMS, or similar.
- Experience delivering enterprise-scale digital/technology/process transformation.
Travel
- Up to 10% domestic and international travel.
Benefits (time off, subject to policy/date of hire)
- Vacation: 120 hours/year; Sick: 40 hours/year (Colorado: 48; Washington: 56); Holiday pay (incl. floating): 13 days/year; Work/Personal/Family Time: up to 40 hours/year; Parental Leave: 480 hours; Bereavement Leave: 240 hours (immediate) / 40 hours (extended); Caregiver Leave: 80 hours (52-week rolling); Volunteer Leave: 32 hours; Military Spouse Time-Off: 80 hours.
Required/Preferred Skills (as listed)
Business Alignment, Compliance Management, Compliance Policies, Developing Others, Inclusive Leadership, ISO 9001, Leadership, Process Improvements, QC, Quality Standards, Quality Systems Documentation, Stakeholder Engagement, SOP, Statistical Process Control (SPC), Systems Thinking, Technical Writing