Otsuka Pharmaceutical Companies (U.S.) · 1 day ago
Senior Manager, Global Quality Management - Clinical
United States
Full-time
Remote
Senior Level
$131K/yr - $196K/yr
6+ years expOtsuka Pharmaceutical Companies (U.S.) is focused on enhancing the quality of clinical trials through effective management and compliance. The Senior Manager of Global Quality Management will oversee clinical quality activities, ensuring adherence to regulations and internal standards while collaborating with various teams to maintain high-quality standards throughout the clinical development lifecycle.
Health CareMedical
Responsibilities
Serve as a GCP quality resource to clinical teams during study planning, conduct, and close-out
Support the review of study documents (e.g., protocols, monitoring plans, vendor agreements) for quality and compliance
Assist in identifying and resolving quality issues, protocol deviations, and potential noncompliance
Collaborate with Clinical Operations, Regulatory Affairs, and Medical Affairs to embed quality practices throughout the study lifecycle
Support inspection readiness activities including mock audits, documentation reviews, and training coordination
Maintain inspection readiness tools, trackers, and communication plans
Participate in regulatory inspections and assist in preparing response documentation
Contribute to the development of the annual audit plan using risk-based approaches
Coordinate and support investigator site, vendor, and internal process audits
Track audit findings and ensure timely implementation of corrective and preventive actions (CAPAs)
Monitor audit trends and escalate recurring issues to senior leadership
Support the implementation and continuous improvement of clinical quality systems, SOPs, and policies
Assist with deviation management, root cause analysis, and CAPA tracking related to clinical activities
Stay current with evolving global GCP regulations and industry best practices
Partner with internal stakeholders and CROs to ensure consistent quality oversight
May mentor junior staff or contractors
Contribute to cross-functional initiatives that promote a culture of quality and compliance
Qualification
Required
Bachelor's degree in life sciences or related field; advanced degree a plus
6–8 years of experience in clinical quality assurance or clinical research within the pharmaceutical or biotech industry
Solid understanding of GCP, ICH guidelines, and global regulatory requirements
Experience supporting inspection readiness and participating in audits or inspections
Strong communication, organizational, and problem-solving skills
Ability to travel domestically and internationally as needed
Proficiency in MS Office (Word, Excel, PowerPoint)
Preferred
Experience with TrackWise or similar quality management systems
Prior collaboration with CROs and external vendors
Exposure to FDA or other health authority inspections
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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