Remote: Global R&D Quality Executive Director

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

Avantages offerts par ce poste

Comprehensive benefits package

Résumé du poste

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team and ensure inspection readiness across clinical trial sites, PV operations, and affiliates.

You will guide QA strategy, align with Regulatory authorities, and drive risk mitigation from development to distribution. The role requires 15+ years in FDA-regulated pharma/medical device environments, strong GCP knowledge, and executive leadership in cross‑functional settings.

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 that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible. Current and in-depth knowledge of audit techniques and government regulatory inspection procedures
• Strong engagement with the OPCJ business will be required warranting a requirement for experience and successful interaction within a Japanese company, or a multi‑national with a Japanese arm.
• Previous experience of working in the global pharmaceutical and medical device industry.
• Experience working with external service providers.
• Working knowledge of current Good Manufacturing Practice (cGMP) regulations.
• Strong project management, leadership, problem solving, and organization skills.
• High level of emotional intelligence.
• Exceptional leadership and team development skills.
• Excellent communication and interpersonal skills.
• Ability to work collaboratively with cross‑functional teams.
• Strategic thinking and problem‑solving abilities.
• Travel (approximately 30%)

Responsabilités

• Inspection Readiness: Ensure continuous inspection readiness across all clinical trial sites, clinical and PV operations.
• Audit Management: Oversee the planning, execution, and follow‑up of internal and external audits to ensure compliance with regulatory requirements.
• Regulatory Authority Engagement: Act as the primary liaison with regulatory authorities, facilitating Clinical and PV inspections and addressing any findings.
• Data Integrity: Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality processes.
• Team Leadership: Lead, mentor, and develop a team of QA professionals, fostering a culture of excellence and continuous improvement.
• Stakeholder Partnership: Collaborate with key stakeholders across the organization to align QA activities with business objectives and regulatory requirements.
• Policy Development: Develops, implements, and maintain policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance.
• Vendor Management: Leads and develops systems for Clinical vendor management and vendor oversight.
• Management Review: Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements.
• Budget Management: Develop and manage the departmental budgets.

Connaissances

Inspection readiness

Audit management

Regulatory engagement

Data integrity

Team leadership

Vendor management

Policy development

Budget management

Strategic thinking

Communication

Formation

Bachelor’s degree

Description du poste

Otsuka America Pharmaceutical Inc. seeks an Executive Director of R&D Global Quality to lead a global team and ensure inspection readiness across clinical trial sites, PV operations, and affiliates.

You will guide QA strategy, align with Regulatory authorities, and drive risk mitigation from development to distribution. The role requires 15+ years in FDA-regulated pharma/medical device environments, strong GCP knowledge, and executive leadership in cross‑functional settings.