Senior Director, Quality Systems (USA)

Role Summary
The Senior Director, Quality Systems provides enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms. Partners with 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.

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).
- Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to align systems with process needs and enterprise priorities.
- Provide quality leadership for strategic system investments to ensure GxP, computerized system validation, and quality requirements are met.
- Develop scalable operational services and support models for consistent, efficient, compliant QMS operations.
- Represent IM Quality Systems in enterprise transformation efforts and governance forums.
- Lead, develop, and engage a global team (accountability, collaboration, inclusion, high performance).
- Monitor internal/external trends to identify opportunities for simplification, standardization, innovation, and value creation.
- Develop dashboards/metrics and leadership updates on system performance, investment progress, risks, and opportunities.

Qualifications
- Bachelor’s degree required.
- 12+ years of relevant experience in Quality Systems, Quality Operations, digital quality, program management, transformation leadership, or related regulated environment.
- Experience with Quality Management System 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.
- Ability to influence senior leaders and matrixed stakeholders.
- Strong strategic, communication, presentation, analytical, and decision-making skills.
- Experience leading teams and creating 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 (e.g., Veeva, TrackWise, ComplianceWire, EDMS, LMS).
- Experience partnering with digital/technology/process ownership/quality organizations for enterprise-scale transformation.
- Experience developing metrics/dashboards and executive-level governance updates.

Travel
- Up to 10% domestic and international travel.

Benefits
- Vacation: 120 hours per calendar year.
- Sick time: 40 hours per calendar year (CO: 48; WA: 56).
- Holiday pay (including 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); 40 hours (extended) per calendar year.
- Caregiver Leave: 80 hours in a 52-week rolling period.
- Volunteer Leave: 32 hours per calendar year.
- Military Spouse Time-Off: 80 hours per calendar year.

Preferred Skills
Business Alignment, Compliance Management, Compliance Policies, Developing Others, Inclusive Leadership, ISO 9001, Leadership, Process Improvements, Quality Control (QC), Quality Standards, Quality Systems Documentation, Stakeholder Engagement, Standard Operating Procedure (SOP), Statistical Process Control (SPC), Systems Thinking, Technical Writing.