Global Quality & Document Management Lead

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 108,000 - 161,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

401(k) match

Tuition reimbursement

Disability insurance

Paid holidays

Job summary

Otsuka Pharmaceutical Co., Ltd. in the United States seeks a Senior Manager to support the governance of GxP documents and the Quality System. You will contribute to continuous improvement, inspection readiness, and global SOP/WP management, collaborating with global/regional teams.

The role requires a quality-focused mindset, coordination across functions, and strong communication in English; experience with regulatory affairs and computer system validation is preferred.

Qualifications

• Degree in natural science or equivalent number of years’ experience.
• 4+ years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation.
• Advanced knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance
• Experience in Monitoring, Quality Assurance and/or Good Clinical Practices

Responsibilities

• Support the development, implementation, continuous improvement and documentation of Otsuka Companies’ Quality System.
• Support inspections
• Support the management of the global, regional and local SOPs and Working Practices (SOPs and WPs)
• Provide advice and act as project liaison, including Monday.com activities

Skills

Change management

MS Office

Communication (English)

Problem solving

Analytical thinking

Education

Degree in natural science

Tools

MS Office

Job description

Otsuka Pharmaceutical Co., Ltd. in the United States seeks a Senior Manager to support the governance of GxP documents and the Quality System. You will contribute to continuous improvement, inspection readiness, and global SOP/WP management, collaborating with global/regional teams.

The role requires a quality-focused mindset, coordination across functions, and strong communication in English; experience with regulatory affairs and computer system validation is preferred.