Otsuka Pharmaceutical Companies (U.S.) · 20 hours ago
Manager, Quality Systems
Princeton, NJ
Full-time
Onsite
Mid, Senior Level
$108K/yr - $161K/yr
6+ years expOtsuka Pharmaceutical Companies (U.S.) is focused on improving the health of patients through innovative pharmaceuticals. The Manager, Quality Systems is responsible for the design, implementation, and continuous improvement of global quality systems that support compliance and operational excellence across the pharmaceutical product lifecycle.
Health CareMedical
Responsibilities
Quality Systems Management: Lead the development, deployment, and governance of core quality systems (e.g., CAPA, Change Control, Deviation Management, Document Management, Training, Audit Management). Serve as the business process owner for quality system platforms, ensuring alignment with business needs and regulatory expectations. Lead or support global projects related to system implementation, validation, and lifecycle management
Process Optimization: Identify and implement process improvements to enhance efficiency, compliance, and user experience across quality systems. Drive process harmonization and standardization across global sites to ensure compliance with regulatory requirements (e.g., FDA, EMA, ICH, ISO)
Digital Transformation: Partner with IT to define and implement digital solutions, system upgrades, and enhancements that improve usability, efficiency, and data integrity
Governance: Develop and maintain governance frameworks, including metrics, dashboards, and KPIs to monitor system performance and compliance
Training & Change Management: Support training initiatives and change management efforts to support global adoption of quality systems and processes
Stakeholder Engagement: Collaborate with cross-functional teams including Regulatory Affairs, Manufacturing, R&D, and Supply Chain to ensure alignment and integration of quality systems
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, Pharmacy, or related field (Master's preferred)
6+ years of experience in pharmaceutical quality, quality systems, or compliance
Proven experience implementing and managing global quality systems in a regulated environment
Experience with eQMS platforms (e.g., Veeva, TrackWise, ComplianceWire)
Strong knowledge of GxP, ICH guidelines, and global regulatory requirements
Excellent project management, analytical, and communication skills
Ability to lead cross-functional initiatives and influence without authority
Familiarity with Lean, Six Sigma, or other continuous improvement methodologies
Preferred
Experience in global or matrixed organizations
Knowledge of risk management frameworks (e.g., ICH Q9)
Experience supporting regulatory inspections and audits
Experience in pharmaceuticals/medical devices or other regulated industry
Embody a customer service mentality as you communicate and support field sales teams
Experience leading Contract Workers remotely
Benefits
Comprehensive medical, dental, vision, prescription drug coverage
Company provided basic life
Accidental death & dismemberment
Short-term and long-term disability insurance
Tuition reimbursement
Student loan assistance
A generous 401(k) match
Flexible time off
Paid holidays
Paid leave programs
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
Recent News
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