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Enterprise Applications Manager
Sumitomo Pharma
- United States
- United States
À propos
Design and define the technical roadmap and architecture for critical GxP systems within Clinical Supply Chain, Quality Management, and Manufacturing.
Lead integration strategies between SAP S/4HANA, Salesforce ATM, and other GxP systems to enhance operational efficiency and compliance.
Translate complex Chain of Custody and Chain of Identity requirements into compliant and scalable system solutions tailored for cell and gene therapy.
GxP, Quality & Compliance Ensure GxP compliance for all managed applications, overseeing validation, change control, documentation, and data integrity processes.
Manage the System Development Life Cycle for regulated systems, including protocol execution and validation report preparation.
Act as the primary contact during regulatory inspections and internal audits for the systems under your management.
Establish and uphold Master Data Quality and Governance processes to ensure data integrity for essential GxP elements.
Management & Execution Guide and mentor a diverse team of analysts, consultants, and integrators, fostering teamwork and professional development.
Oversee project execution, managing scope, budget, resources, and timelines for significant system initiatives.
Develop and maintain relationships with vendors to ensure effective service delivery and successful system implementation and support.
Required Qualifications Experience & Functional Expertise A minimum of 8 years of experience in managing enterprise systems within the Pharmaceutical or Biotech sectors.
Proven expertise in leading transformations involving SAP S/4HANA across multiple modules.
Hands-on experience with Salesforce Health Cloud and Advanced Therapy Management, particularly in patient and cell journey orchestration.
Strong understanding of GxP regulations and a track record of validating regulated computer systems.
Experience with Master Data Management principles and implementing solutions in regulated settings.
Familiarity with cell and gene therapy processes, including Chain of Custody and Identity, is a strong plus.
Education & Technical Skills Bachelor's or Master's degree in Computer Science, Engineering, Life Sciences, or a related discipline.
Excellent skills in managing complex system integrations, with experience in SAP CPI or similar technologies.
Outstanding leadership, communication, and stakeholder engagement abilities to effectively convey intricate technical concepts to varied audiences.
The base salary for this role is between $125,600 and $157,000. Our total rewards package features merit-based salary increases, eligibility for short incentive plans, and comprehensive benefits, including 401(k) plans, medical/dental/vision insurance, and generous paid time off. Actual total compensation will reflect individual experience and qualifications. Equal Opportunity Employment : Sumitomo Pharma America is an Equal Employment Opportunity employer. We value diversity and encourage applicants from all backgrounds to apply. At Sumitomo Pharma America, our mission is driven by innovative research and development, positively impacting healthcare worldwide.
Compétences linguistiques
- English
Avis aux utilisateurs
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