Senior Director, Quality Systems (USA)
Johnson & Johnson
June 26, 2026
Remote friendly (New Brunswick, NJ)
United States
Operations
Role Summary
The Senior Director, Quality Systems will provide enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms for compliant, efficient, modern GxP quality processes across Innovative Medicine.
Key Responsibilities
- Lead global QMS systems strategy, investment roadmap, and governance model.
- Oversee planning, execution, sustainment, and continuous improvement of QMS system initiatives and investments.
- Serve as business owner for core QMS systems and enabling platforms (LMS, EDMS, QMS workflows, and related operational capabilities).
- Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders.
- Provide Quality leadership for strategic system investments to ensure compliance with applicable GxP, computerized system validation, and quality requirements.
- Develop scalable operational services and support models for consistent, efficient, compliant QMS operations.
- Represent IM Quality Systems in enterprise transformation and governance forums.
- Lead, develop, and engage a global team.
- Monitor internal/external trends and identify opportunities for simplification, standardization, innovation, and value creation.
- Develop dashboards, metrics, and leadership updates on QMS performance, investment progress, risks, and opportunities.
Qualifications
- Bachelor’s degree required.
- Minimum 12 years relevant experience in Quality Systems/Quality Operations/digital quality/program management/transformation leadership or a related regulated environment.
- Experience with Quality Management System platforms supporting GxP processes.
- Demonstrated experience shaping roadmaps and leading system investments.
- Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement.
- Ability to influence senior leaders and global matrixed stakeholders.
- Strong strategic, communication, presentation, analytical, and decision-making skills.
- Experience leading teams and building inclusive, high-performance environments.
- Ability to manage multiple priorities in a complex global organization.
Preferred Qualifications
- Advanced degree (M.S., MBA, Ph.D., Pharm.D., or equivalent).
- Experience in pharmaceuticals/healthcare/medical technology or other highly regulated industries.
- Experience with QMS platforms such as Veeva, TrackWise, ComplianceWire, EDMS, LMS, or similar systems.
- Experience partnering with digital/technology/process ownership/quality organizations for enterprise transformation.
Travel
- Up to 10% domestic and international travel as needed.
Benefits
- Vacation: 120 hours per calendar year; Sick time: 40 hours per calendar year (Colorado: 48; Washington: 56); Holiday pay incl. Floating Holidays: 13 days/year; Work/Personal/Family Time up to 40 hours/year; Parental Leave: 480 hours within one year; Bereavement Leave: 240 hours (immediate) and 40 hours (extended); Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year.
The Senior Director, Quality Systems will provide enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms for compliant, efficient, modern GxP quality processes across Innovative Medicine.
Key Responsibilities
- Lead global QMS systems strategy, investment roadmap, and governance model.
- Oversee planning, execution, sustainment, and continuous improvement of QMS system initiatives and investments.
- Serve as business owner for core QMS systems and enabling platforms (LMS, EDMS, QMS workflows, and related operational capabilities).
- Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders.
- Provide Quality leadership for strategic system investments to ensure compliance with applicable GxP, computerized system validation, and quality requirements.
- Develop scalable operational services and support models for consistent, efficient, compliant QMS operations.
- Represent IM Quality Systems in enterprise transformation and governance forums.
- Lead, develop, and engage a global team.
- Monitor internal/external trends and identify opportunities for simplification, standardization, innovation, and value creation.
- Develop dashboards, metrics, and leadership updates on QMS performance, investment progress, risks, and opportunities.
Qualifications
- Bachelor’s degree required.
- Minimum 12 years relevant experience in Quality Systems/Quality Operations/digital quality/program management/transformation leadership or a related regulated environment.
- Experience with Quality Management System platforms supporting GxP processes.
- Demonstrated experience shaping roadmaps and leading system investments.
- Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement.
- Ability to influence senior leaders and global matrixed stakeholders.
- Strong strategic, communication, presentation, analytical, and decision-making skills.
- Experience leading teams and building inclusive, high-performance environments.
- Ability to manage multiple priorities in a complex global organization.
Preferred Qualifications
- Advanced degree (M.S., MBA, Ph.D., Pharm.D., or equivalent).
- Experience in pharmaceuticals/healthcare/medical technology or other highly regulated industries.
- Experience with QMS platforms such as Veeva, TrackWise, ComplianceWire, EDMS, LMS, or similar systems.
- Experience partnering with digital/technology/process ownership/quality organizations for enterprise transformation.
Travel
- Up to 10% domestic and international travel as needed.
Benefits
- Vacation: 120 hours per calendar year; Sick time: 40 hours per calendar year (Colorado: 48; Washington: 56); Holiday pay incl. Floating Holidays: 13 days/year; Work/Personal/Family Time up to 40 hours/year; Parental Leave: 480 hours within one year; Bereavement Leave: 240 hours (immediate) and 40 hours (extended); Caregiver Leave: 80 hours in a 52-week rolling period; Volunteer Leave: 32 hours/year; Military Spouse Time-Off: 80 hours/year.