Remote Executive Director, Global R&D Quality

Otsuka America Pharmaceutical Inc.

Boise (ID)

Remote

USD 250,000 - 388,000

Full time

3 days ago

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Job summary

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global QA organization. This role directs quality for R&D, GCQ, CSV and GPV, with direct US reporting and dotted line reporting in Asia, Europe and North America.

The leader ensures end-to-end quality across development through distribution and maintains data integrity. The role requires strategic leadership, cross-functional collaboration and risk-based decision making to sustain GCP/QSR

Qualifications

Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device environment.
Strong knowledge of global GCP for designing, recording and reporting trials.
Experience with external service providers and regulatory inspections.
Proven leadership in global Quality and regulatory environments.

Responsibilities

Inspire and develop a team of QA professionals and partners.
Ensure inspection readiness across clinical and PV operations and health authority inspections.
Lead audit programs and communicate findings with timely corrective actions.
Establish and maintain policies for quality and compliance across business units.
Oversee vendor management and management reviews per QSR standards.
Manage budgets and liaise with senior management on risk mitigation.