Global R&D Quality Exec - Remote Leadership & Compliance

Otsuka America Pharmaceutical Inc.; City of Albany (NY); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) match

Paid holidays

Paid time off

Tuition reimbursem ent

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team across US and international affiliates. You will ensure inspection readiness, oversee clinical trial and submission support, and drive the audit program and regulatory engagements.

The role requires strategic direction for GCQ, CSV, and GPV, with a focus on end-to-end quality from development through commercial distribution. ~30% travel expected.

Qualifications

• Bachelor’s degree and 15+ years in FDA regulated pharmaceutical and/or medical device environment.
• Strong knowledge of global GCP for trials; regulatory inspection procedures.
• Experience leading global QA with cross-regional oversight and Japanese business engagement.
• Experience working with external service providers and vendors.

Responsibilities

• Inspire and develop a team of QA professionals and align with GQ strategy.
• Ensure sites are inspection ready and manage health authority inspections.
• Lead clinical facility and system audits across sites and vendors.
• Develop and maintain quality management and compliance programs.
• Report quality performance to Senior Management via Management Review.

Skills

Leadership

GCP knowledge

Regulatory inspections

Audit techniques

Cross-functional collaboration

Strategic thinking

Problem solving

Communication

Education

Bachelor’s degree

15+ years pharma/med dev experience

Job description

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team across US and international affiliates. You will ensure inspection readiness, oversee clinical trial and submission support, and drive the audit program and regulatory engagements.

The role requires strategic direction for GCQ, CSV, and GPV, with a focus on end-to-end quality from development through commercial distribution. ~30% travel expected.