Global Quality Systems Manager & Analytics

Otsuka

United States

Remote

USD 108,000 - 161,000

Full time

29 hours ago

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Benefits offered by this job

Comprehensive medical coverage

Dental coverage

Vision coverage

401(k) match

Paid holidays and leave

Job summary

Otsuka is seeking a Manager, Quality Systems to lead global electronic Quality Management System initiatives. You will collaborate with Quality, IT, and cross-functional teams to implement, optimize, and sustain eQMS solutions, aligning processes with GxP standards and data governance.

The role emphasizes dashboards, reporting, and AI-enabled analytics. Candidates should have 4+ years in pharmaceutical Quality or Quality Systems, with TrackWise Digital or Veeva experience, and a strong focus on

Qualifications

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Information Systems, Data/Analytics, or related field; Master's preferred.
4+ years of experience in pharmaceutical Quality, Quality Systems, compliance, or related regulated environment.
Experience with electronic Quality Management Systems (eQMS) such as TrackWise Digital or Veeva.
Experience supporting system implementations, enhancements, upgrades, integrations, or lifecycle activities.

Responsibilities

Support the implementation, maintenance, enhancement, validation, and lifecycle management of global eQMS solutions.
Partner with Quality process owners, IT, and stakeholders to ensure system functionality supports processes and compliance.
Assist with global system implementations, upgrades, integrations, and other Quality technology initiatives.
Define metrics, KPIs, reports, and dashboards for Quality performance and analytics.
Identify issues and coordinate solutions with business and technical stakeholders; drive continuous improvement.