Global R&D Quality Leader (Remote)

Otsuka America Pharmaceutical Inc.

Olympia (WA)

Remote

USD 250,000 - 388,000

Full time

7 days ago

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Job summary

Otsuka America Pharmaceutical Inc. is seeking an Executive Director of R&D Global Quality to lead a worldwide quality function.

The role covers GQ strategy, clinical quality, CSV, and GPV with direct/indirect reports across regions, ensuring inspection readiness and data integrity. The leader will guide global quality processes, mitigate risks from development through distribution, and partner with business units to harmonize quality systems while reporting to Senior Management via the

Qualifications

Bachelor’s degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device environment.
Strong knowledge of current global GCP for designing, recording and reporting trials.
Experience with audits, regulatory inspections, and external service providers.
Excellent leadership, communication, and cross-functional collaboration skills.
Willingness to travel ~30%.

Responsibilities

Inspire and develop a team of Quality professionals and partner with stakeholders to deliver Global Quality strategy.
Ensure inspection readiness across clinical trial sites and PV operations, and manage CAPAs for effectiveness.
Lead audits of clinical facilities, sites, and vendors and ensure timely corrective actions.
Develop standards and procedures for quality management, risk mitigation, and regulatory compliance.