Global R&D Quality Executive Leader

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical, Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global team focused on R&D Quality. The role ensures inspection readiness across sites, oversees clinical trial and submission support, and drives the audit program.

The leader will guide Global Clinical Quality (GCQ), CSV and GPV, partnering with global regions to harmonize processes and mitigate quality risks from development through distribution.

Qualifications

• Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment.
• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials.
• Experience with external service providers and global audits.

Responsibilities

• Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites and PV operations.
• Audit Management: Oversee internal and external audits to ensure regulatory compliance.
• Regulatory Authority Engagement: Liaise with regulatory authorities for inspections and findings.
• Data Integrity: Ensure accuracy and reliability of clinical and PV data through quality processes.
• Team Leadership: Lead and develop QA professionals and foster continuous improvement.
• Stakeholder Partnership: Align QA activities with business objectives and regulatory requirements.
• Policy Development: Develop and maintain QA policies and procedures for GCP/QSR compliance.
• Vendor Management: Manage clinical vendors and oversight.
• Management Review: Conduct R&D management reviews per QSR and company requirements.
• Budget Management: Develop and manage departmental budgets.

Skills

Executive leadership

Quality systems

Regulatory affairs

Global leadership

Auditing

GCP knowledge

cGMP knowledge

Education

Bachelor’s degree

Job description

Otsuka America Pharmaceutical, Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global team focused on R&D Quality. The role ensures inspection readiness across sites, oversees clinical trial and submission support, and drives the audit program.

The leader will guide Global Clinical Quality (GCQ), CSV and GPV, partnering with global regions to harmonize processes and mitigate quality risks from development through distribution.