Manager, Quality Systems

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🔥 1 minute ago

🇺🇸 United States – Remote

💵 $107.7k - $161k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 0%

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Support implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System solutions • Partner with Quality process owners, IT, and stakeholders to ensure system functionality supports business processes, compliance requirements, and organizational needs • Support global system implementations, upgrades, enhancements, integrations, and Quality technology initiatives • Provide centralized expertise and support for reliable, scalable, and consistent use of Quality Systems across global functions and affiliates • Identify system issues, opportunities, and enhancement needs and coordinate solutions • Assess workflows and identify opportunities to improve efficiency, compliance, usability, and scalability • Support harmonization and standardization of Quality System processes and workflows • Facilitate requirements gathering, process mapping, future-state design, testing, and implementation of system enhancements • Apply continuous improvement methodologies to reduce complexity, improve cycle times, and enhance user experience • Monitor system and process performance to identify recurring issues, bottlenecks, and improvement opportunities • Define metrics, KPIs, reports, and dashboards for Quality performance, compliance, risks, and trends • Develop and maintain reports and dashboards using Quality Systems and related data sources • Improve accessibility, usability, completeness, consistency, accuracy, and usability of Quality data • Resolve data quality issues and strengthen upstream data capture • Identify and implement digital solutions, including artificial intelligence, automation, advanced analytics, and emerging technologies • Support requirements gathering and evaluation of AI-enabled solutions • Support change management and communications for system implementations, enhancements, and process changes • Partner with Training and process owners to promote user understanding and adoption • Develop or support user guidance, communications, reference materials, and adoption tools • Gather user feedback to improve system usability and support • Collaborate across Global Quality, IT, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Clinical, and other business functions • Translate business needs into system, reporting, analytics, and data requirements • Build relationships across global and matrixed teams and facilitate stakeholder alignment • Support global affiliates and functional teams in adopting standardized Quality System capabilities

🎯 Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or a related field • 4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment • Demonstrated experience supporting electronic Quality Management Systems and associated business processes • Experience with eQMS platforms such as TrackWise Digital, Veeva, or similar eQMS platforms • Experience supporting system implementations, enhancements, upgrades, integrations, or lifecycle management activities • Experience developing, maintaining, or supporting reports, metrics, dashboards, and data-driven performance monitoring • Experience working within global or matrixed organizations and collaborating across business and technology functions • Strong understanding of GxP principles, ICH guidelines, and pharmaceutical Quality System expectations • Ability to translate business requirements into system, workflow, reporting, and analytics solutions • Strong process improvement and problem-solving capabilities • Excellent communication and stakeholder-management skills • Preferred: experience developing or supporting Quality dashboards and performance analytics • Preferred: understanding of AI, machine learning, generative AI, intelligent automation, or advanced analytics and their potential application within regulated Quality environments

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Incentive opportunity

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