Remote Global R&D Quality Executive Leader

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) match

Tuition reimbursement

Student loan assistance

Flexible time off

Paid holidays

Job summary

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team overseeing R&D quality, audits, and regulatory engagement. The role covers Global Clinical Quality, CSV, and GPV with dotted-line reporting to Asia, Europe and North America.

You will drive inspection readiness, risk mitigation, and continuous improvement across affiliate sites, partnering with business groups to ensure end-to-end quality in development through distribution.

Qualifications

• Bachelors degree and 15+ years in FDA-regulated pharma/medical device environments.
• Strong knowledge of GCP for designing, recording and reporting trials; audit techniques and inspections.
• Experience working with external service providers; global pharma/medical device exposure.
• Familiar with cGMP regulations and risk-based quality management.
• Proven leadership, project management, problem-solving and communication skills.
• Willingness to travel ~30% and engage with global teams.

Responsibilities

• Inspire and develop a QA team and partner with stakeholders to deliver Global Quality strategy.
• Ensure inspection readiness across sites and manage health authority inspections.
• Lead audits and ensure corrective actions are implemented and effective.
• Engage with regulatory authorities and maintain data integrity across PV/clinical data.
• Develop and maintain quality policies and vendor oversight for GQ programs.
• Oversee management reviews and budget planning for the QA function.

Skills

GCP knowledge

Regulatory audits

Audit techniques

External vendors

cGMP knowledge

Project leadership

Travel 30%

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team overseeing R&D quality, audits, and regulatory engagement. The role covers Global Clinical Quality, CSV, and GPV with dotted-line reporting to Asia, Europe and North America.

You will drive inspection readiness, risk mitigation, and continuous improvement across affiliate sites, partnering with business groups to ensure end-to-end quality in development through distribution.