Executive Director, Global R&D Quality & Compliance

Otsuka Pharmaceutical Companies (U.S.); United States; In loco; USD 250.000 - 388.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental, vision insurance

401(k) match

Paid time off

Tuition reimbursement

Descrizione del lavoro

Otsuka Pharmaceutical Companies (U.S.) seeks an Executive Director of R&D Global Quality to lead a global quality organization supporting R&D. The role oversees audits, regulatory interactions, and data integrity across affiliates with US and international reporting lines, ensuring inspection readiness and strategic quality management.

The leader will drive cross-functional collaboration, develop team capabilities, and manage risk with a focus on GCP/QSR compliance and continuous

Competenze

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment
• Strong knowledge of current global GCP for designing, recording and reporting trials
• Experience with external service providers and familiarity with Japanese business environments

Mansioni

• Inspire and develop a team of Quality professionals and deliver GQ strategy
• Ensure sites are inspection ready and lead health authority inspections
• Lead clinical facility and system audits and ensure corrective actions are implemented
• Establish standards for quality management and mitigate compliance risks

Conoscenze

GCP knowledge

Leadership

Regulatory compliance

Quality management

Cross-functional collaboration

Formazione

Bachelor’s degree

Descrizione del lavoro

Otsuka Pharmaceutical Companies (U.S.) seeks an Executive Director of R&D Global Quality to lead a global quality organization supporting R&D. The role oversees audits, regulatory interactions, and data integrity across affiliates with US and international reporting lines, ensuring inspection readiness and strategic quality management.

The leader will drive cross-functional collaboration, develop team capabilities, and manage risk with a focus on GCP/QSR compliance and continuous