Senior Director, Quality Systems – Innovative Medicine Quality & Compliance Johnson & Johnson's Innovative Medicine Quality & Compliance, Quality Management & Digital team seeks a global leader to shape, operate, and continuously improve the Quality Management System (QMS) technology and operational landscape supporting GxP quality processes.
Role Summary The Senior Director will provide enterprise leadership for the strategy, roadmap, operation, and sustainment of core QMS systems and enabling platforms, partnering with cross‐functional stakeholders to align systems with business priorities, regulatory expectations, inspection readiness, and continuous improvement.
Key Responsibilities Lead the 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, etc.).
Partner with Global Process Owners, Enterprise Quality, IM Digital Quality, JJT, and regional stakeholders to ensure alignment with process needs and enterprise priorities.
Provide quality leadership and guidance for strategic system investments, ensuring compliance with GxP, computerized system validation, and quality requirements.
Develop scalable operational services and support models enabling 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.
Qualifications Bachelor's degree required.
Minimum 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 supporting GxP processes.
Demonstrated experience shaping system roadmaps, leading system investments, and translating business needs into executable plans.
Strong knowledge 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.
Preferred Qualifications Advanced degree (M.S., MBA, Ph.D., Pharm.D., or equivalent).
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 on enterprise‐scale transformation.
Experience developing metrics, dashboards, and executive‐level updates to support decision‐making and governance.
Travel Up to 10% domestic and international travel may be required based on business needs.
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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Contact Details:
7360-Janssen-Cilag Limited Legal Entity Recruitment Team