Remote Global R&D Quality Executive Director

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

Benefits offered by this job

401(k) match

Comprehensive benefits package

Tuition reimbursement

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global quality function with direct reports in the U.S. and dotted lines in Asia, Europe and North America.

The role ensures inspection readiness, oversees clinical trial and submission support, and advances the R&D audit program. You will shape the Global Quality strategy, harmonize processes across regions, manage risk from development to commercialization, and report to Senior Management on

Qualifications

• Bachelor’s degree in a FDA-regulated pharma/medical device field.
• 15+ years in a regulated pharmaceutical/medical device environment.
• Deep knowledge of GCP, cGMP and audit procedures.
• Experience with global/regional regulatory engagement and inspections.

Responsibilities

• Inspire and develop a QA team, align with senior stakeholders on strategy.
• Ensure inspection readiness for all clinical sites and PV operations.
• Oversee internal/external audits and drive corrective actions.
• Engage with regulatory authorities and manage clinical data integrity.
• Lead and optimize QA systems, risk management, and governance.
• Manage budgets and lead cross-functional QA initiatives.
• Develop and maintain global QA policies, procedures, and vendor oversight.
• Report Quality performance through Management Review processes.
• Travel as needed to support global quality operations (~30%).

Skills

Leadership

Quality management

Regulatory affairs

Audits

Cross-functional

Clinical quality

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global quality function with direct reports in the U.S. and dotted lines in Asia, Europe and North America.

The role ensures inspection readiness, oversees clinical trial and submission support, and advances the R&D audit program. You will shape the Global Quality strategy, harmonize processes across regions, manage risk from development to commercialization, and report to Senior Management on