Senior Director, Quality Systems (USA)
About The Position
The Senior Director, Quality Systems is a global leadership role responsible for shaping, operating, and continuously improving the Quality Management System technology and operational landscape that enables compliant, efficient, and modern GxP quality processes across Innovative Medicine. This role provides enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms. The leader will partner closely with various quality and digital teams, Global Process Owners, and regional stakeholders to ensure QMS systems support business priorities, regulatory expectations, inspection readiness, and continuous improvement. The role will lead global QMS system strategy, business ownership, system investment planning, and operational services, including support for Transcend, QMS Operations, LMS, EDMS, and related QMS workflows. Additionally, this leader will provide strategic direction, people leadership, governance, and stakeholder engagement to advance a scalable, compliant, and digitally enabled QMS ecosystem.
Requirements
- Bachelor’s degree is required.
- Minimum of 12 years of relevant experience in Quality Systems, Quality Operations, digital quality, program management, transformation leadership, or a related regulated environment.
- Experience with Quality Management System platforms and solutions supporting GxP processes.
- Demonstrated experience shaping system roadmaps, leading system investments, and translating business needs into executable plans.
- Strong understanding of quality systems, regulatory expectations, computerized system validation, and continuous improvement principles.
- Proven ability to influence, collaborate, and drive alignment across senior leaders, global teams, and matrixed stakeholders.
- Strong strategic thinking, communication, presentation, analytical, and decision-making skills.
- Experience leading teams, developing talent, and creating an inclusive, high-performance team environment.
- Ability to manage multiple priorities and deliver high-quality outcomes in a complex, global organization.
Nice To Haves
- Advanced degree such as M.S., MBA, Ph.D., Pharm.D., or equivalent is preferred.
- Experience in pharmaceuticals, healthcare, medical technology, or another highly regulated industry.
- Experience with QMS platforms such as Veeva, TrackWise, ComplianceWire, EDMS, LMS, or similar systems.
- Experience partnering with digital, technology, process ownership, and quality organizations to deliver enterprise-scale transformation.
- Experience developing metrics, dashboards, and executive-level updates to support decision-making and governance.
Responsibilities
- Lead the global QMS systems strategy, investment roadmap, and governance model to support current and future Innovative Medicine Quality & Compliance priorities.
- Oversee planning, execution, sustainment, and continuous improvement of QMS system initiatives and investments.
- Serve as business owner for core QMS systems and enabling platforms, including LMS, EDMS, QMS workflows, and related operational capabilities.
- Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to ensure systems are aligned with process needs, quality architecture, and enterprise priorities.
- Provide Quality leadership and guidance for strategic system investments, ensuring compliance with applicable GxP, computerized system validation, and quality requirements.
- Develop scalable operational services and support models that enable consistent, efficient, and compliant QMS operations.
- Represent IM Quality Systems in enterprise transformation efforts, governance forums, and senior leadership discussions.
- Lead, develop, and engage a global team, fostering accountability, collaboration, inclusion, and high performance.
- Monitor internal and external trends in Quality Systems and digital capability to identify opportunities for simplification, standardization, innovation, and value creation.
- Develop dashboards, metrics, and leadership updates to provide visibility into QMS system performance, investment progress, risks, and opportunities.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year (varies by state)
- 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 the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member 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
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What This Job Offers
Job Type
Full-time
Career Level
Director
