Executive Director, R&D – Global Quality

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $250k - $388.1k / year

⏰ Full Time

🔴 Lead

👔 Director

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Lead a global team focused on R&D Quality • Ensure OAPI, OPDC, and affiliates are inspection ready • Oversee clinical trial and submission support • Lead the R&D audit program • Engage with regulatory authorities • Maintain clinical data integrity • Provide vision, guidance, strategic direction, and leadership for R&D Global Quality and the Global Quality function • Partner with business groups and global regions to assure end-to-end Quality and harmonize processes • Identify and mitigate Quality risks from development through commercial registration and product distribution • Inspire and develop Quality professionals and partner with key stakeholders • Ensure internal and external sites are inspection ready and provide resources during health authority inspections • Ensure findings are appropriately addressed and CAPAs are implemented and checked for effectiveness • Analyze findings and assess systemic trends • Lead clinical facility and system audits at facilities, investigator sites, and vendors • Establish standards and implement quality-management and compliance procedures • Report Quality Systems and Risks to Senior Management through Management Review • Ensure continuous inspection readiness across clinical trial sites and clinical and Pharmacovigilance operations • Oversee planning, execution, and follow-up of internal and external audits • Act as primary liaison with regulatory authorities • Ensure accuracy, consistency, and reliability of clinical and PV data • Lead, mentor, and develop QA professionals • Collaborate with stakeholders to align QA activities with business and regulatory requirements • Develop, implement, and maintain policies, systems, and procedures for quality and compliance • Lead systems for clinical vendor management and vendor oversight • Establish and maintain R&D Management Reviews • Develop and manage departmental budgets

🎯 Requirements

• 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) • Current and in-depth knowledge of audit techniques and government regulatory inspection procedures • Experience and successful interaction within a Japanese company, or a multinational with a Japanese arm • Previous experience 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 organizational 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 • Approximately 30% travel

🏖️ Benefits

• Incentive opportunity • Comprehensive medical coverage • Dental coverage • Vision coverage • Prescription drug coverage • Company-provided basic life insurance • Accidental death & dismemberment insurance • Short-term disability insurance • Long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits