Remote Global R&D Quality Executive Director

Otsuka America Pharmaceutical Inc.; San Juan (PR); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401(k) match

Paid time off

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team focused on development to distribution. This role drives inspection readiness, regulatory engagement, and data integrity across OAPI, OPDC, and affiliates.

The leader will shape strategy for GCQ, CSV, and GPV, partnering with global regions to harmonize processes and mitigate risks while ensuring compliance with GCP and cGMP across development programs.

Qualifications

• Bachelor’s degree with 15+ years in FDA-regulated pharma/medical device environments.
• Strong knowledge of GCP for trial design, recording and reporting.
• Experience with global regulatory inspections and audit techniques.
• Proven leadership of QA professionals across global teams.
• Engagement with multiple regions and external service providers.
• Experience with cGMP regulations and vendor oversight.
• Excellent communication and cross-functional collaboration skills.

Responsibilities

• Inspire and develop a QA team and align with Global Quality strategy.
• Ensure inspection readiness and manage inspection support across sites.
• Lead audit planning, execution, and corrective actions.
• Engage regulatory authorities and address findings efficiently.
• Oversee data integrity and risk mitigation across development to distribution.
• Develop and maintain QA policies, systems, and training programs.
• Manage budgets and vendor relationships; report through MR process.

Skills

GCP knowledge

Regulatory inspections

Auditing techniques

Leadership

Cross-functional collaboration

cGMP knowledge

Vendor management

Regulatory affairs

Strategic thinking

Travel readiness

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team focused on development to distribution. This role drives inspection readiness, regulatory engagement, and data integrity across OAPI, OPDC, and affiliates.

The leader will shape strategy for GCQ, CSV, and GPV, partnering with global regions to harmonize processes and mitigate risks while ensuring compliance with GCP and cGMP across development programs.