Manager, Quality Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the implementation, maintenance, enhancement, validation, and lifecycle management of global electronic Quality Management System solutions.

• Collaborate with Quality process owners, IT, and stakeholders to ensure that system functionality aligns with business processes, compliance requirements, and organizational needs.

• Support global system implementations, upgrades, enhancements, integrations, and Quality technology initiatives.

• Provide centralized expertise and support for the effective, scalable, and consistent utilization of Quality Systems across global functions and affiliates.

• Identify system issues, opportunities, and enhancement requirements, and coordinate solutions.

• Evaluate workflows and pinpoint opportunities for improving efficiency, compliance, usability, and scalability.

• Assist in the harmonization and standardization of Quality System processes and workflows.

• Facilitate requirements gathering, process mapping, future-state design, testing, and implementation of system enhancements.

• Utilize continuous improvement methodologies to minimize complexity, enhance cycle times, and improve user experience.

• Monitor system and process performance to identify recurring issues, bottlenecks, and opportunities for improvement.

• Define metrics, KPIs, reports, and dashboards to assess Quality performance, compliance, risks, and trends.

• Develop and maintain reports and dashboards utilizing Quality Systems and related data sources.

• Enhance the accessibility, usability, completeness, consistency, and accuracy of Quality data.

• Address data quality issues and improve upstream data capture.

• Identify and implement digital solutions, including artificial intelligence, automation, advanced analytics, and emerging technologies.

• Assist in the requirements gathering and evaluation of AI-enabled solutions.

• Support change management and communication efforts for system implementations, enhancements, and process modifications.

• Partner with Training and process owners to foster user understanding and adoption.

• Develop or assist in creating user guidance, communications, reference materials, and adoption tools.

• Collect user feedback to enhance 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.

• Cultivate relationships across global and matrixed teams to facilitate stakeholder alignment.

• Assist 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.

• Over 4 years of experience in pharmaceutical Quality, Quality Systems, compliance, business systems, data/analytics, or a related regulated environment.

• Proven experience in supporting electronic Quality Management Systems and associated business processes.

• Familiarity with eQMS platforms such as TrackWise Digital, Veeva, or similar eQMS platforms.

• Experience in supporting system implementations, enhancements, upgrades, integrations, or lifecycle management activities.

• Experience in 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 capabilities in process improvement and problem-solving.

• Excellent communication and stakeholder management skills.

• Preferred: experience in developing or supporting Quality dashboards and performance analytics.

• Preferred: knowledge of AI, machine learning, generative AI, intelligent automation, or advanced analytics and their potential applications 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 opportunities.