Remote Global R&D Quality Director

Otsuka America Pharmaceutical Inc.; Boston (MA); À distance; USD 250 000 - 388 000; Plein temps

Résumé du poste

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global QA team focused on ensuring inspection readiness across development and clinical operations.

This role will drive the QA strategy, oversee audits, and engage with regulatory authorities to maintain data integrity and compliance. The leader will guide Global Clinical Quality, CSV and GPV, partner with business groups and regions, and identify risks to implement effective

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 working with external service providers.
• Experience in global pharmaceutical/medical device industry.
• Working knowledge of cGMP regulations.
• Strong leadership, project management, problem solving and communication skills.
• Willingness to travel approximately 30%.
• Experience engaging with cross-functional teams and regulatory authorities.

Responsabilités

• Inspire and develop a QA team across US and international affiliates and deliver the Global Quality strategy.
• Ensure inspection readiness across clinical trial sites and PV operations, coordinate inspections and CAPA responses.
• Lead audits (internal, external, regulatory) and ensure timely corrective actions and effectiveness checks.
• Establish standards and procedures for QA programs identifying, detecting and mitigating non-compliance.
• Oversee Vendor management for clinical vendors and associated oversight.
• Report QA performance to senior management via Management Review and risk mitigation.

Connaissances

Executive leadership

Global QA

Regulatory relationships

Quality systems

Audits

Team development

Formation

Bachelor’s degree

Description du poste

Otsuka America Pharmaceutical Inc. is seeking an experienced Executive Director of R&D Global Quality to lead a global QA team focused on ensuring inspection readiness across development and clinical operations.

This role will drive the QA strategy, oversee audits, and engage with regulatory authorities to maintain data integrity and compliance. The leader will guide Global Clinical Quality, CSV and GPV, partner with business groups and regions, and identify risks to implement effective