Remote Global R&D Quality Executive

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

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave programs

Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a global QA team across US, Asia, Europe and North America, ensuring inspection readiness and end-to-end quality from development through distribution.

The role oversees Global Clinical Quality, CSV and GPV, partners with regional teams to harmonize processes and mitigate risk, and leads audit programs with regulatory authorities.

Qualifications

• Bachelor’s degree and 15+ years in FDA regulated pharma/medical device industries.
• Strong knowledge of GCP for trial design, conduct and reporting; audit techniques and regulatory inspections.
• Experience with Japanese partner environments or multi-nationals with Japanese arms.
• Global pharma/medical device industry experience; external service provider management.
• Knowledge of cGMP regulations and risk-based quality systems.

Responsibilities

• Inspire and develop a QA team; partner with stakeholders; implement Global Quality strategy.
• Ensure inspection readiness across sites; manage inspections remotely/on-site during inspections.
• Lead clinical facility/system audits; ensure corrective actions and timely documentation.
• Develop and maintain QA policies; manage compliance programs and risk mitigation within GQ.

Skills

GCP knowledge

Audit techniques

Global QA leadership

Regulatory engagement

Project management

Communication skills

Quality systems

Vendors & CK oversight

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 across US, Asia, Europe and North America, ensuring inspection readiness and end-to-end quality from development through distribution.

The role oversees Global Clinical Quality, CSV and GPV, partners with regional teams to harmonize processes and mitigate risk, and leads audit programs with regulatory authorities.