Remote Global R&D Quality Executive Director

Otsuka America Pharmaceutical Inc.; Trenton (NJ); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision,

401(k) match

Paid time off

Disability insurance

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a worldwide quality organization spanning R&D, clinical operations, and pharmacovigilance with a focus on ensuring inspection readiness and data integrity.

You will drive the global quality strategy, oversee audits, and partner with affiliates to harmonize processes and mitigate development-to-commercial risks.

Qualifications

• Bachelor’s degree required; 15+ years in FDA-regulated pharma/medical device environments preferred.
• Strong knowledge of current global GCP for designing, recording and reporting trials; experience with audits and regulatory inspections.
• Experience collaborating with cross-functional teams and external service providers.
• Proven leadership, project management, problem-solving and communication skills.
• Ability to travel ~30% to support inspections, audits and alliance partners.

Responsibilities

• Inspire and develop a QA team; partner with stakeholders to execute the Global Quality strategy.
• Ensure sites are inspection-ready; manage inspections and CAPA execution with timely closure.
• Lead audits of clinical facilities, systems, sites, and vendors; ensure timely corrective actions.
• Establish standards and procedures to ensure effective quality management and risk mitigation.
• Provide periodic updates to Senior Management via Management Review processes.
• Lead and develop clinical vendor management and oversight.

Skills

Leadership

Regulatory engagement

Quality systems

Audit management

GxP compliance

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a worldwide quality organization spanning R&D, clinical operations, and pharmacovigilance with a focus on ensuring inspection readiness and data integrity.

You will drive the global quality strategy, oversee audits, and partner with affiliates to harmonize processes and mitigate development-to-commercial risks.