Senior Director,Quality Systems Job Trenton area,New Jersey USA,Quality Assurance

Position: Senior Director, Quality Systems (USA)

Senior Director, Quality Systems (global leadership role)
Role Summary

Provide enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms.
Partner with Innovative Medicine Quality & Compliance, Enterprise Quality, IM Digital Quality, JJT, Global Process Owners, and regional stakeholders to ensure QMS systems support business priorities, regulatory expectations, inspection readiness, and continuous improvement.
Lead global QMS system strategy, business ownership, system investment planning, and operational services (supporting Transcend, QMS Operations, LMS, EDMS, and related QMS workflows). Provide strategic direction, people leadership, governance, and stakeholder engagement to advance a scalable, compliant, digitally enabled QMS ecosystem.

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, related operational capabilities).
Provide Quality leadership for strategic system investments (GxP, computerized system validation, quality requirements).
Develop scalable operational services/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 to identify opportunities for simplification, standardization, innovation, and value creation.
Develop dashboards/metrics/leadership updates on system 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 in a regulated environment.
Experience with QMS platforms supporting GxP processes.
Demonstrated experience shaping roadmaps, leading investments, and translating business needs into executable plans.
Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement.
Proven ability to influence/collaborate across senior leaders and matrixed stakeholders.
Strong strategic thinking, communication, presentation, analytical, and decision‑making skills.
Experience leading teams and fostering 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 industry.
Experience with QMS platforms (Veeva, Track Wise, Compliance Wire, EDMS, LMS, or similar).
Experience partnering with digital/technology/process ownership/quality organizations for enterprise-scale transformation.
Experience developing metrics/dashboards for executive-level updates.

Travel

Up to 10% domestic and international travel based on business needs.

Required/Preferred Skills

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 per calendar year
Work, Personal and Family Time: up to 40 hours per calendar year
Parental Leave: 480 hours within one year of birth/adoption/foster care
Bereavement Leave: 240 hours immediate family; 40 hours extended family per year
Caregiver Leave: 80 hours in a 52-week rolling period (10 days)
Volunteer Leave: 32 hours per calendar year
Military Spouse Time-Off: 80 hours per calendar year

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